BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1772051 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09531
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 14, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED 480 MG/DL AND 209 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK COMPACT PLUS SYSTEM. SHE TOOK EXTRA INSULIN. SHE ALSO DRANK OJ AND (B)(6). SHE STATES THAT SHE FELT BETTER IN 30 MINUTES. 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 20663541

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NOVOLOG SLIDING SCALE 3X/DAY - 5+ YEARS| PREVACID 30 MG/DAY - 2 YEARS| VIVELLE - 0.2 MG/WEEK - 10 YEARS| LEVEMIR - 16 UNITS/DAY - 3 MONTHS