BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 838616 · Received March 26, 2007

    Report

    Report Number
    1823260-2007-02400
    Event Type
    Malfunction
    Date Received
    March 26, 2007
    Date of Event
    February 28, 2007
    Report Date
    March 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPACT TEST DRUM IS THE SUSPECT PRODUCT.

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING BACK-TO-BACK RESULTS OF 25MG/DL AND 71 MG/DL ON THE COMPACT SYSTEM. AT THE TIME THE RESULTS WERE OBTAINED, PATIENT WAS NOT EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA. PATIENT INDICATED THAT THERAPY WAS NOT MODIFIED BASED ON THESE VALUES. NO PATIENT INJURY WAS REPORTED AND NO TREATMENT WAS RECEIVED. QUALITY CONTROL TESTING WAS NOT PERFORMED ON THE COMPACT SYSTEM. PATIENT DID NOT PROVIDE THE LOCATION WHERE THE DISCREPANT RESULTS WERE OBTAINED. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED. COMPACT SYSTEM :METER, COMPACT STRIP LOT 2061144 WITH EXPIRATION 11/30/2007.

    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 * 20641144

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NIASPAN 500MG| SULINDAC 50MG| GLYBURDIE/METFORMIN 500MG| MICARDIS 80MG| LIPITOR 10MG| COREG 25MG| PLAIX 75 MG| ACTOS 45MG