BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002121 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01712
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 20, 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

    THE REPORTER STATES THAT THE ACCU-CHEK COMFORT CURVE STRIPS WERE DUE TO EXPIRE IN 2008. THE MFR EXPIRATION DATE IS 08/31/2004. NO ADVERSE EVENT REPORTED. NO THIRD PARTY INTERVENTION REQUIRED. THE REPORTER WAS NOT AWARE THAT THE ACCU-CHEK COMFORT CURVE STRIPS WERE EXPIRED. NEW SYS SENT AND RETURN REQUESTED.

    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 546459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK