BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1053167 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04313
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE ACCU-CHEK AVIVA STRIP EXPIRATION DATE IS 09/31/2009. THE ELECTRONIC INVENTORY SYSTEM EXPIRATION DATE FOR THE STRIPS IS 07/31/2009. BATCH RECORD VERIFICATION ALSO CONFIRMED THE EXPIRATION DATE AS 07/31/2009. THE REPORTER WAS NOT AWARE THAT THE ACCU-CHEK AVIVA STRIPS WERE EXPIRED. NO ACTIONS TAKEN OR TREATMENT GIVEN BASED ON EVENT. NO ADVERSE EVENT REPORTED. NEW STRIPS SENT AND RETURN REQUESTED.

    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 301074

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR