BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1934019 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07592
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 11, 2010
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM (LOT NUMBER 551195, EXPIRATION DATE 04/30/2011). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT IN THE 30S (MG/DL) ON THE AVIVA SYSTEM AND RESULT IN THE 80S (MG/DL) ON THE ADVANTAGE SYSTEM USING COMFORT CURVE TEST STRIPS WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF 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 ROCHE DIAGNOSTICS NA 551195

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR OXYGEN AT NIGHT