BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1781022 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06545
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF HI AND 241 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 20660641

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR METFORMIN 1000MG AM/500MG PM - AFTER 7/12| GLYBURIDE 4MG TWICE DAILY - AFTER 7/12| AVANDIA 4MG TWICE DAILY - BEFORE 5/29| METFORMIN 500MG TWICE DAILY- BEFORE 07/12| ZETIA 10MG DAILY| DIOVAN 160MG DAILY