BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3051580 · Received April 10, 2013

    Report

    Report Number
    2954323-2013-00211
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 8, 2013
    Product Code
    NBW
    PMA / PMN Number
    120568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A METER ISSUE ONLY, AND THE FREESTYLE INSULINX BLOOD GLUCOSE TEST STRIPS ARE NOT IMPACTED BY THIS ISSUE. THE ISSUE AFFECTS THE FOLLOWING US MODEL NUMBERS -71142-70, 71143-70, 71145-70, AND 71150-70. THE FOLLOWING MODEL NUMBERS ARE FOR AFFECTED INSULINX METER OUTSIDE OF THE US, 71144-70, 71146-70, 71147-70, 71148-70, 71149-70, 71152-70, 71153-70, AND 71236-70. THIS ISSUE IS CAUSED BY A SOFTWARE DEFECT RELATED IN THE MANNER IN WHICH THE FREESTYLE INSULINX METER CALCULATES THE BLOOD GLUCOSE VALUE USING 16 BIT LOGIC, AND CONVERTS THIS VALUE TO A 10 BIT LOGIC FOR DISPLAY AND STORAGE IN THE METER. ADC INFORMED THE FDA OF THIS ISSUE (ADC INTERNAL RECALL NUMBER ADC FA1023-2013) BY PHONE ON (B)(4) 2013. NOTIFICATION LETTERS TO ALL AFFECTED CONSIGNEES WILL COMMENCE ON APRIL 15, 2013. NOTE: THE DEVICE MANUFACTURE DATE IS NOT APPLICABLE. THE MONTH AND YEAR ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THIS 5-DAY INITIAL MEDICAL DEVICE REPORT (MDR) IS NOT RELATED TO A SPECIFIC CUSTOMER COMPLAINT, BUT INSTEAD IS BEING SUBMITTED IN ACCORDANCE WITH 21CFR803.53(A). ABBOTT DIABETES CARE (ADC) HAS IDENTIFIED THAT AT EXTREMELY HIGH BLOOD GLUCOSE LEVELS OF 1024 MG/DL AND ABOVE, THE FREESTYLE INSULINX METER WILL DISPLAY AND STORE IN ITS MEMORY AN INCORRECT TEST RESULT THAT IS 1024 MG/DL BELOW THE MEASURED RESULT. IF THE FREESTYLE INSULINX METER DISPLAYS AN INACCURATE LOW RESULT, THERE MAY BE A DELAY IN THE IDENTIFICATION AND TREATMENT OF SEVERE HYPERGLYCEMIA, OR INCORRECT TREATMENT. THE LIKELIHOOD OF EXPERIENCING EXTREMELY HIGH BLOOD GLUCOSE LEVELS SUCH AS 1024 MG/DL AND ABOVE IS RARE. HOWEVER, WHEN THEY OCCUR, IT IS A SERIOUS HEALTH RISK AND REQUIRES IMMEDIATE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149215 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1