BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 855683 · Received May 24, 2007

    Report

    Report Number
    1823260-2007-04464
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    May 6, 2007
    Report Date
    May 24, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 222, 144, & 85 MG/DL WHEN ALL TESTS WERE PREFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER STATED SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT THE TIME SO SHE SELF TREATED WITH FOOD. NO OTHER ACTIONS TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549226

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR METFORMIN 1YR - 1000MG TWICE DAILY| UNK PAIN PILL - AS NEEDED