BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781019 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06534
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS BEING SUBMITTED FOR INFORM SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED BACK-TO-BACK BLOOD GLUCOSE RESULTS ON 2 INFORM METERS: INFORM SYSTEM 1 = 44 MG/DL AND INFORM SYSTEM 2 = 130 MG/DL WITHIN 5 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT 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 - LFR LFR ROCHE DIAGNOSTICS 549636

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR