BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3840889 · Received May 30, 2014

    Report

    Report Number
    2954323-2014-00606
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 3, 2014
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, THE REPORTED READINGS WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG WITHIN 10 MINUTES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 276 MG/DL AND 66 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318562 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1371110

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR