BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1021775 · Received March 20, 2008

    Report

    Report Number
    1823260-2008-02620
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK COMPACT SYSTEM 2. REFERENCE MEDWATCH WITH A1 PATIENT FOR SUSPECT DEVICE ACCU-CHEK COMPACT SYSTEM 1.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED A 600 MG/DL ON ACCU-CHEK COMPACT SYSTEM 1 AND A BLOOD GLUCOSE RESULT OF 216 MG/DL ON ACCU-CHEK COMPACT SYSTEM 2. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN BASED ON THE BLOOD GLUCOSE RESULTS. 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 206621

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR PIOGLITAZONE 45 MG/DAY - 4 YEARS| DIOVAN HCT 160 MG/DAY - 6 MONTHS