BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220295 · Received November 3, 2008

    Report

    Report Number
    1823260-2008-08121
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE OF 2008. A REVIEW OF THE BATCH RECORDS BY THE MANUFACTURING SITE CONFIRMS THE EXPIRATION DATE IS ACTUALLY 2005. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. RETURN OF THE SUSPECT PRODUCT WAS REQUESTED; 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 548013

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 70/30 INSULIN - 35 UNITS PM| 70/30 INSULIN - 50 UNITS AM