BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1012751 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02347
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 298, 300, 199, 89, 63, AND 64 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE COMPACT SYS. REPORTER STATED THE CUSTOMER WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD 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 20664861

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR GLUCOPHAGE| COZAAR| ZOCOR| AMARYL