BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1063584 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04876
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ACCU-CHEK COMFORT CURVE STRIP EXPIRATION DATE IS 04/2008. THE ELECTRONIC INVENTORY SYSTEM EXPIRATION DATE FOR THE STRIPS IS 12/31/2007. BATCH RECORD VERIFICATION ALSO CONFIRMED THE EXPIRATION DATE AS 12/31/2007. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW STRIPS SENT AND RETURN REQUESTED. THE CUSTOMER STATES THAT SHE HAS DISCARDED THE ACCU-CHEK COMFORT CURVE STRIPS.

    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 549408

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR