BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMPACT TEST DRUM

    MDR report key: 983227 · Received January 23, 2008

    Report

    Report Number
    1823260-2008-00769
    Event Type
    Malfunction
    Date Received
    January 23, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES, THAT SHE OBTAINED THE BLOOD GLUCOSE RESULTS OF 80MG/DL AND 284MG/DL ON THE ACCU-CHEK COMPACT PLUS METER. THE RESULTS WERE OBTAINED WITHIN 10 MINUTES. SHE TREATED HERSELF WITH OJ AND FELT BETTER 20 MINUTES AFTERWARD. NO ADVERSE EVENT REPORTED. NEW SYS SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20661341

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR GLYBURIDE-METFORMIN 1000MG/D