BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1110225 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05174
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 25, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 215 MG/DL ON HER ADVANTAGE SYSTEM COMPARED TO A RESULT OF 112 MG/DL WHEN MEASURED AT THE CLINIC AT THE SAME TIME. NO ACTIONS 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549060

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR