BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1514000 · Received October 12, 2009

    Report

    Report Number
    1823260-2009-06999
    Event Type
    Malfunction
    Date Received
    October 12, 2009
    Date of Event
    October 4, 2009
    Report Date
    October 12, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE USE BY DATE ON THE ACTIVE TEST STRIPS VIAL AS 04/2009. MFR'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 04/30/2008. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22952533

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK