BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1141426 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05497
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 456 MG/DL AND 118 MG/DL ON THE ACCUCHEK ACTIVE S SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NBW NBW ROCHE DIAGNOSTICS 22981031

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR GLYBURIDE - 7 YEARS| GLUCOPHAGE - 7 YEARS