BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1122865 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-06229
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    June 25, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 113 MG/DL AND 270 MG/DL ON THE ACCU-CHEK COMPACT SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED SYMPTOMS. THE CUSTOMER DRANK ORANGE JUICE AND RETESTED AN UNDISCLOSED TIME LATER AND OBTAINED THE BLOOD GLUCOSE RESULT OF 107 MG/DL. 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 COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IRON - 1.5 YEARS| SYNTHROID -14 YEARS| MULTIVITAMIN - SEVERAL YEARS| AMARYL- 4 YEARS| TRICOR - 3 YEARS| GLUCOPHAGE- 4 YEARS