BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1032681 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03415
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    November 25, 2007
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT COMFORT CURVE BLOOD GLUCOSE TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE OF 08/31/07. THE MFR'S BATCH RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 08/31/06. NO ACTIONS OR TREATMENT WERE REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. NO ADVERSE EVENT 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 TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 548531

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NOVOLOG 70/30