BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1141425 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05496
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 14, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A "LO" (LESS THAN 10 MG/DL) ON THE ACCU-CHEK ACTIVE SYSTEM. DUE TO THE "LO" (LESS THAN 10 MG/DL) RESULT, SHE ATE A FEW PIECES OF CANTALOUPE AND DRANK A CUP OF APPLE JUICE. SHE RAN ANOTHER TEST AND OBTAINED THE BG RESULT OF 115 MG/DL ON THE SAME SYSTEM. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. THE CUSTOMER FELT DIZZY, WITH BLURRY EYES AND DIFFICULTY FOCUSING DURING THE EVENT. SHE STATES THAT THE SYMPTOMS WERE UNRELATED TO DIABETES AND SHE HAS EXPERIENCED THEM FOR THE PAST 4 WEEKS. 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 22978331

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR METFORMIN ER