BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1771135 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01232
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF: 293 MG/DL AND 123 MG/DL; 293 MG/DL AND 114 MG/DL. NO QUALITY CONTROL INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 65 YR SIMVASTATIN 40 MG/DAY| SYNTHROID 100 MCG/DAY| SINGULAR 10 MG/DAY