BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1220062 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08068
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A 22MG/DL AND 62MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK COMPACT PLUS SYSTEM. THE CUSTOMER STATES SHE OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 31MG/DL AND 80MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINS. THE CUSTOMER FELT HYPOGLYCEMIC WITH THE 22MG/DL BLOOD GLUCOSE RESULT. THE CUSTOMER ATE A HANDFUL OF JELLY BEANS AND FELT BETTER WITHIN 15 MINS. NO REPORTED SYMPTOMS/ACTIONS/TREATMENT WITH THE SECOND SET OF BLOOD GLUCOSE COMPARISON. 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 CORP. 20677141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HUMULIN 70/30 - 8 MOS| LASICS - 15 YRS| VERAPARIL - 15 YRS| B12 - 15 YRS| TRAMADOL - 6 MOS| HYDROCODONE - 5 YRS| CAPATRIL - 15 YRS| FLEXERIL (MUSCLE RELAXER) - 10 YRS| HUMULIN NPH - 10 YRS| CRESTOR - 8 YRS