BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761313 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06371
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 7, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 288 MG/DL, HI (GREATER THAN 600 MG/DL), AND 141 MG/DL WHEN TESTING WAS PERFORMED WITHIN 5 MINUTE ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS AND DID NOT REPORT ANY TREATMENT/ACTION BASED ON RESULTS. NO ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 20659241

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR FOLBEE - 5 YEARS - DAILY| TRICORE - 4 YEARS - 145MG DAILY| AMARYL - 7 YEARS - 1MG DAILY| LIPITOR - 4 YEARS - 10M DAILY