BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761002 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06165
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    July 4, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 357 MG/DL AND 128 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE COMPACT SYSTEM. CUSTOMER REPORTED NO SYMPTOMS AND WITHHELD NOVOLOG BASED ON THE 128 MG/DL RESULT. NO ADVERSE EVENT WAS REPORTED. 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 20657642

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LISINOPRIL - ABOUT 1 YEAR - 10 MG DAILY| BUMETANIDE - ABOUT 2 YEARS - 1MG DAILY| PLAVIX - ABOUT 2.5 YEARS - 75 MG DAILY| LANTUS - ABOUT 2 YEARS - 8 UNITS DAILY| ACTOPLUS MET- ABOUT 1.5 YEAR-15/850MG TWICE DAILY| NOVOLOG - ABOUT 1.5 YEARS - SLIDING SCALE