BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1083771 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05763
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK COMPACT PLUS SYSTEM WITHIN TEN MINUTES: 107MG/DL, 173MG/DL AND 96MG/DL. NO REPORTED ACTIONS TAKEN. 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 20676341

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SINGULAIR - 1 WEEK| LASIX - 1 WEEK| OXYCODLAPAP - 1 WEEK| CYANOCOBALAM - 1 WEEK| KLOCCON - 1 WEEK| KEFLET" - 1 WEEK| PCOTONIX - 1 WEEK| ALBUTEROL - 1 WEEK| HYDROCHLOROTHID - 1 YEAR| VASOTEC - 1 WEEK| FLEXALIL - 1 WEEK| ADVAIR DISKUS - 3 MONTHS