By Danielle Daley

FDA MedWatch – INRatio and INRatio2 PT/INR Monitor System by Alere

KCER Release Date: July 13, 2016

Audience: ESRD Networks and Facilities, Nephrologists, Dialysis Staff

INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results

ISSUE: Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System.

BACKGROUND: In December 2014, Alere initiated a voluntary correction to inform users of the INRatio and INRatio2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system. As part of its commitment to ensuring the safety of patients, Alere proactively reported these device concerns to the FDA and began conducting a thorough investigation into these events.

Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.

Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.

RECOMMENDATION: Alere is committed to ensuring an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. We suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Press Release, at:

CDC Request

Undetermined Cause of Cardiac Arrest During Hemodialysis, 2015

The Connecticut Department of Public Health (CT DPH) has received reports of six patients that experienced sudden cardiovascular collapse leading to cardiac arrest during routine outpatient hemodialysis; three of the six expired.  Four cases occurred in one clinic on 12/18, 12/19, and 1/12.  There have been two other cases, one on 12/18 in a separate clinic, and one on 12/30, in a third clinic.  These events occurred 30 to 135 minutes after the initiation of the hemodialysis treatment and not immediately following administration of a medication.

The three cases who expired had findings suggestive of an anaphylactic reaction (airway edema noted clinically and/or during autopsy and elevated serum tryptase level).

While such events can occur among hemodialysis patients during their treatment, this number of these events clustered in time appears to be unusual; therefore, CT DPH and the Centers for Disease Control and Prevention (CDC) are collaborating on an investigation.  Possible etiologies under consideration include contamination of medications or medical devices.

Requested Actions

CDC is requesting notification about similar cases that may have occurred in other dialysis centers from November 2015 to present.

Specifically requesting notification of the following: (1) a patient who had cardiovascular collapse and/or cardiac arrest during hemodialysis with signs/symptoms of anaphylaxis; (2) a patient who had severe anaphylactic reaction during hemodialysis without cardiac arrest; or (3) two or more patients in the same facility who had cardiac arrest without anaphylaxis that occurred during hemodialysis and within 24 hours of each other; from November 2015 to the present.

Please forward this notification to

Flu Season Begins: Severe Influenza Illness Reported


Distributed via the CDC Health Alert Network
February 1, 2016, 0850 EST (8:50 AM EST)

CDC urges rapid antiviral treatment of very ill and high risk suspect influenza patients without waiting for testing


Influenza activity is increasing across the country and CDC has received reports of severe influenza illness. Clinicians are reminded to treat suspected influenza in high-risk outpatients, those with progressive disease, and all hospitalized patients with antiviral medications as soon as possible, regardless of negative rapid influenza diagnostic test (RIDT) results and without waiting for RT-PCR testing results. Early antiviral treatment works best, but treatment may offer benefit when started up to 4-5 days after symptom onset in hospitalized patients. Early antiviral treatment can reduce influenza morbidity and mortality.

Since October 2015, CDC has detected co-circulation of influenza A(H3N2), A(H1N1)pdm09, and influenza B viruses. However, H1N1pdm09 viruses have predominated in recent weeks. CDC has received recent reports of severe respiratory illness among young- to middle-aged adults with H1N1pdm09 virus infection, some of whom required intensive care unit (ICU) admission; fatalities have been reported. Some of these patients reportedly tested negative for influenza by RIDT; their influenza diagnosis was made later with molecular assays. Most of these patients were reportedly unvaccinated. H1N1pdm09 virus infection in the past has caused severe illness in some children and young- and middle-aged adults. Clinicians should continue efforts to vaccinate patients this season for as long as influenza viruses are circulating, and promptly start antiviral treatment of severely ill and high-risk patients if influenza is suspected or confirmed.


  1. Clinicians should encourage all patients who have not yet received an influenza vaccine this season to be vaccinated against influenza. This recommendation is for patients 6 months of age and older. There are several influenza vaccine options for the 2015-2016 influenza season (see ), and all available vaccine formulations this season contain A(H3N2), A(H1N1)pdm09, and B virus strains. CDC does not recommend one influenza vaccine formulation over another.
  1. Clinicians should encourage all persons with influenza-like illness who are at high risk for influenza complications (see list below) to seek care promptly to determine if treatment with influenza antiviral medications is warranted.
  1. Decisions about starting antiviral treatment should not wait for laboratory confirmation of influenza. Clinicians using RIDTs to inform treatment decisions should use caution in interpreting negative RIDT results. These tests, defined here as rapid antigen detection tests using immunoassays or immunofluorescence assays, have a high potential for false negative results. Antiviral treatment should not be withheld from patients with suspected influenza, even if they test negative by RIDT; initiation of empiric antiviral therapy, if warranted, should not be delayed.
  1. CDC guidelines for influenza antiviral use during 2015-16 season are the same as during prior seasons (see ).
  1. When indicated, antiviral treatment should be started as soon as possible after illness onset, ideally within 48 hours of symptom onset. Clinical benefit is greatest when antiviral treatment is administered early. However, antiviral treatment might still be beneficial in patients with severe, complicated, or progressive illness, and in hospitalized patients and in some outpatients when started after 48 hours of illness onset, as indicated by clinical and observational studies.
  1. Treatment with an appropriate neuraminidase inhibitor antiviral drugs (oral oseltamivir, inhaled zanamivir, or intravenous peramivir) is recommended as early as possible for any patient with confirmed or suspected influenza who
    • is hospitalized;
    • has severe, complicated, or progressive illness; or
    • is at higher risk for influenza complications. This list includes:

– children aged younger than 2 years;

– adults aged 65 years and older;

– persons with chronic pulmonary (including asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (including sickle cell disease), metabolic disorders (including diabetes mellitus), or neurologic and neurodevelopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury);

– persons with immunosuppression, including that caused by medications or by HIV infection;

– women who are pregnant or postpartum (within 2 weeks after delivery);

– persons aged younger than 19 years who are receiving long-term aspirin therapy;

– American Indians/Alaska Natives;

– persons who are morbidly obese (i.e., body-mass index is equal to or greater than 40); and

– residents of nursing homes and other chronic-care facilities.

  1. Antiviral treatment can also be considered for suspected or confirmed influenza in previously healthy, symptomatic outpatients not at high risk on the basis of clinical judgment, especially if treatment can be initiated within 48 hours of illness onset.
  1. Clinical judgment, on the basis of the patient’s disease severity and progression, age, underlying medical conditions, likelihood of influenza, and time since onset of symptoms, is important when making antiviral treatment decisions for outpatients.
  1. While influenza vaccination is the best way to prevent influenza, a history of influenza vaccination does not rule out influenza virus infection in an ill patient with clinical signs and symptoms compatible with influenza. Vaccination status should not impede the initiation of prompt antiviral treatment.


Seasonal influenza contributes to substantial morbidity and mortality each year in the United States. In the most recent influenza season—the 2014-2015 season—CDC estimates that there were approximately 19 million influenza-associated medical visits and 970,000 influenza-associated hospitalizations [1]. The spectrum of illness observed thus far during the 2015-2016 season has ranged from mild to severe and is consistent with that of other influenza seasons. Although influenza activity nationally is low compared to this time last season, it is increasing; and some localized areas of the United States are already experiencing high activity. Further increases are expected in the coming weeks. Typically, influenza seasons begin with increases in influenza-like-illness and the percent of respiratory specimens testing positive for influenza in clinical laboratories. Those indicators are rising at this time. Increases in severity indicators tend to lag behind. At this time, national surveillance systems that track severity are not elevated, but CDC will continue to watch for indications of increased severity from influenza virus infection this season.

Laboratory data so far show that most circulating flu viruses are still like the viruses recommended for the 2015-2016 influenza vaccines. CDC will continue to monitor circulating influenza viruses for changes that might impact vaccine effectiveness and publish these data weekly in FluView (http:/ CDC also is conducting epidemiologic field studies to determine vaccine effectiveness this season.

For more information:

  1. Summary of Weekly U.S. Influenza Surveillance Report (http:/
  2. People at High Risk of Developing Flu–Related Complications (
  3. Clinical Signs and Symptoms of Influenza (
  4. ACIP Recommendations for the Prevention and Control of Influenza with Vaccines, United States, 2015-16: Summary for Clinicians (
  5. Influenza Antiviral Medications: Summary for Clinicians (
  6. Guidance for Clinicians on the Use of Rapid Influenza Diagnostic Tests (
  7. Prevention Strategies for Seasonal Influenza in Healthcare Settings (
  8. Guidance for the Prevention and Control of Influenza in the Peri- and Postpartum Settings (
  9. Interim Guidance for Influenza Outbreak Management in Long-Term Care Facilities (
  10. Patient Education: Influenza Brochures, Fact Sheets, and Posters (


  1. Centers for Disease Control and Prevention. Estimated influenza illnesses and hospitalizations averted by influenza vaccination – United States, 2014-15 influenza season. (

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.


CDC Urging Dialysis Providers and Facilities to Assess and Improve Infection Control Practices to Stop Hepatitis C Virus Transmission in Patients Undergoing Hemodialysis

Distributed via the CDC Health Alert Network
January 27, 2016, 1030 EST (10:30 AM EST)

Summary The Centers for Disease Control and Prevention (CDC) has received an increased number of reports of newly acquired hepatitis C virus (HCV) infection among patients undergoing hemodialysis. Infection control lapses in dialysis care could expose patients to HCV. Any case of new HCV infection in a patient undergoing hemodialysis should prompt immediate action. CDC is urging dialysis providers and facilities to:

1) Assess current infection control practices and environmental cleaning and disinfection practices within the facility to ensure adherence to infection control standards; 2) Address any gaps identified by the assessments; 3) Screen patients for HCV, following CDC guidelines, to detect infections, determine treatment potential, and halt secondary transmission; and 4) Promptly report all acute HCV infections to the state or local health department.

Background CDC has received an increased number of reports of acute HCV infection among patients undergoing hemodialysis. Between 2014 and 2015, CDC has been contacted about 36 cases of acute HCV infection in 19 different hemodialysis clinics in eight states. While investigations are ongoing, so far, HCV transmission between patients has been demonstrated at nine of those clinics, based on epidemiologic and viral sequencing evidence. Lapses in infection control (e.g., injection safety, environmental disinfection, and hand hygiene) were commonly identified at these facilities. Although the exact means of transmission could not be discerned, these lapses all could potentially contribute to HCV transmission. The increase in acute HCV infections might be due, in part, to improved screening and awareness of the potential for HCV infection in the hemodialysis setting. Regardless, this increase underscores the widespread potential for patients to acquire serious infections during dialysis care.

Dialysis facilities should actively assess and continuously improve their infection control, environmental cleaning and disinfection, and HCV screening practices, whether or not they are aware of infections in their clinic. Any case of new HCV infection in a patient undergoing hemodialysis is likely to be a healthcare-associated infection and should be reported to public health authorities in a timely manner. A recent publication describes a dialysis facility where an outbreak of HCV continued for five years before being detected, highlighting the importance of HCV screening to identify these infections early and prevent further transmission.1  HCV transmission can be prevented when proper infection prevention and environmental disinfection practices are consistently followed.

Recommendations In response to the increased identification of HCV transmission in dialysis clinics, CDC recommends the following actions be followed:

Dialysis providers

  • Evaluate infection control practices in each facility and ensure adherence to infection control standards.
  • If gaps are identified, promptly address any issues to protect patients’ health and safety (
  • Ensure staff are aware of and trained to implement infection control guidelines ( for hemodialysis settings.3,4 Facilities should provide regular (e.g., annual) training ( of staff to ensure adherence to infection control recommendations.3,4
  • Follow CDC recommendations for HCV screening of hemodialysis patients and management of patients who test positive:
    • CDC recommends that chronic hemodialysis patients be screened for HCV antibody12,13 (anti-HCV) ( upon admission to the dialysis clinic and every six months thereafter if susceptible to HCV infection.5
    • For those patients with a positive anti-HCV test result, the test should be followed with a Nucleic Acid Test (NAT) for HCV RNA.6 Follow CDC recommendations for interpretation of test results and further actions.7 Ensure patients identified to have HCV infection are aware of the diagnosis and are referred to appropriate care and evaluation. Persons with chronic HCV infection, including those with end-stage renal disease, may benefit from treatment.
  • Immediately report any case of new HCV infection among patients undergoing hemodialysis to the state or local health department.5,8
    • New HCV infection can present as a change in anti-HCV status from negative to positive, in the absence of signs or symptoms.
    • Communicate test results to the patient and arrange for clinical evaluation for possible treatment of HCV infection.
    • Determine the HCV infection status of all other patients receiving care in the facility.
  • Be transparent. Inform patients if HCV transmission is suspected to have occurred within the facility, and explain steps being taken to address the problem.

Health departments

  • Investigate any acute HCV infection in a hemodialysis patient for a possible healthcare-associated etiology.9


  • If you do not know if you have or might have hepatitis C, ask your healthcare provider.
  • Ask your healthcare providers questions about your dialysis care, such as:
    • Do you follow CDC recommendations?
    • Do I need to be tested for hepatitis C virus?
    • What can be done to prevent me from getting an infection during my dialysis treatment?
  • Review educational resources for patients ( on dialysis safety and hepatitis C10,11( provided by CDC and other partners.

Additional Resources

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.