BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1001775 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01669
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 39 MG/DL AND HI (RESULT GREATER THEN 600 MG/DL) WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. AT 8-10 MINS FOLLOWING THE RESULT OF HI, CUSTOMER RECEIVED RESULT OF 175 MG/DL. SEVERAL WEEKS AGO, CUSTOMER ALSO REPORTEDLY RECEIVED RESULTS OF 400 MG/DL AND 130 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE 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 20673943

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR OCTREOTIDE 150 MG 8/DAY 8 MONTHS