BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1022335 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02816
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE COMPACT PLUS SYS WITH RESULTS OF 89MG/DL ON THE CUSTOMER'S METER AND 36MG/DL ON THE PROFESSIONAL METER. CUSTOMER REPORTS HAVING LOW BLOOD GLUCOSE SYMPTOMS; WAS ABLE TO CONSUME TREATMENT ON HER OWN. NO QUALITY CONTROLS WERE RUN. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR GLIPIZIDE 10MG/DAY - 4 YEARS| HUMULIN 70/30 10 UNITS 2X/DAY - 2-3YRS