BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1011746 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02326
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE FOLLOWING BLOOD GLUCOSE COMPARISON RESULTS ON THE ACCU-CHEK COMPACT PLUS SYSTEM: 434 MG/DL AND 185 MG/DL; 236 MG/DL AND 595 MG/DL; 185 MG/DL AND 595 MG/DL. ALL AFOREMENTIONED TESTS WERE OBTAINED WITHIN 10 MINUTES. NO REPORTED ACTIONS TAKEN. 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 20675541

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR EFFEXOR XR 150MG/DAY - 3 YEARS| NIASPAN 1000MG/DAY - 2 YEARS| FOSAMAX PLUS D 70MG/WEEK - 1 YEAR| BYETTA 1000MG/DAY - 3 WEEKS| "TORPROL" 100MG/DAY - 4 YEARS| METFORMIN 2000MG/DAY - 4 MONTHS