BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 728281 · Received June 16, 2006

    Report

    Report Number
    1823260-2006-02886
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 29, 2006
    Report Date
    May 30, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BLOOD GLUCOSE MEASURED 277, 193, 102, AND 94 MG/DL WHEN ALL TESTS WERE PERFORMED BACK TO BACK WITHIN ONE MINUTE OF EACH OTHER. NO ACTIONS TAKEN AND NO TREATMENT RECEIVED AS A RESULT. 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 TEST STRIPS NBW ROCHE DIAGNOSTICS NA 548724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DIGOXIN, COUMADIN, TRIQUINIDE.| ACCU-CHEK ADVANTAGE METER, GLYBURIDE,