BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1780205 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08256
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 21, 2007
    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 REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF: 80 MG/DL TO 200 MG/DL; 531 MG/DL TO 80 MG/DL; 80 MG/DL TO 187 MG/DL; 531 MG/DL TO 187 MG/DL; 531 MG/DL TO 206 MG/DL; 531 MG/DL TO 213 MG/DL; 80 MG/DL TO 206 MG/DL; 80 MG/DL TO 213 MG/DL. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. CUSTOMER DOES NOT HAVE STRIP DRUM; 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR TRIHEXYPHENIDYL - 5MG 3X/DAY - 2-3 MONTHS| PREDNISONE AS NEEDED - 13-14 YEARS| XANAX - 1MG 4X/DAY - 6-7 YEARS| SEROQUEL - 300MG 3 TABS/PM - 7-8 YEARS| SONATA - 10MG DAILY - 3 YEARS| PROZAC - 20MG DAILY - 6 MONTHS| VISTARIL - 50MG DAILY - 8 YEARS| TOPAMAX - 100MG DAILY - 5-6 YEARS| METFORMIN - 850MG 2X/DAY - 3 YEARS| INVEGA - 6MG DAILY - 6 MONTHS| METHADONE - 5MG 5X/DAY - 2 MONTHS| ALBUTEROL AS NEEDED - 12 YEARS