BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1760848 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06057
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE COMPACT SYSTEM GENERATED A RESULT OF 0 MG/DL WHICH IS OUTSIDE THE READING RANGE OF 10-600 MG/DL AND WHEN GLUCOSE IS BELOW 10 MG/DL IS DISPLAYED AS LO. REPORTER STATED SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING AND THE DISPLAY CHECK WAS SUCCESSFUL INDICATING THE PRESENCE OF ALL ICONS AND NUMBERS WHEN IT WAS PERFORMED ON THE SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT 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 BLOOD GLUCOSE MONITORING DEVICE - NBW LFR ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AVANDIA + METFORMIN - 3 YRS 4/1000MG TWICE DAILY