BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761265 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06429
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 84 MG/DL AND 244 MG/DL WHEN TESTS WERE PERFORMED WITHIN 1 MINUTE ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS AND SELF-TREATED WITH CEREAL AND SUGAR. 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 71 YR GLIPIZIDE - 10 MG TWICE DAILY