BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052031 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04179
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE USE BY DATE ON THE AVIVA STRIP VIAL IS 06/2008; MANUFACTURER'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 04/30/2008. THE STRIP VIAL IS ERRONEOUSLY LABELED, POSSIBLY ALLOWING CUSTOMER TO TEST BEYOND ACTUAL EXPIRATION DATE. NO ADVERSE EVENT REPORTED. BATCH RECORD EXPIRATION DATE CONFIRMATION ATTACHED. REQUESTED RETURN OF PRODUCT, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK