BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1061068 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04716
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS STRIP VIAL EXPIRATION DATE AS 05/30/2008 WHILE USING AVIVA TEST STRIPS. MANUFACTURER'S ELECTRONIC INVENTORY RECORDS SHOW EXPIRATION DATE AS 04/30/2008. BATCH RECORD VERIFICATION SHOWS EXPIRATION DATE AS 04/30/2008. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS 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 CORP. 300424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK