BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1022681 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02906
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 29, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 446 MG/DL AND 138 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 20675141

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NOVOLOG 70/30 20UNITS AM - 2.5 YEARS| NOVOLOG 70/30 14UNITS PM - 2.5 YEARS