BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1781061 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06522
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 14, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 116, 289, AND 68 MG/DL WHEN TESTING WAS PERFORMED A FEW MINUTES APART ON THE COMPACT SYSTEM. REPORTER STATED HE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER INDICATED SELF TREATING WITH EITHER FOOD OR SOMETHING TO DRINK, BUT WAS NOT CERTAIN AS TO WHICH TYPE OF TREATMENT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20662141

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HUMULIN N - SEVERAL YRS - 20-25UNITS SLIDING SCALE