BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1070096 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05156
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLES HAVE EXPIRED; THEREFORE, ONLY HISTORICAL DATE IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE USE BY DATE OF THE TEST STRIP VIAL AS 10/31/2007; MANUFACTURER'S ELECTRONIC INVENTORY SYSTEM AND BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 02/29/2004. 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 22867532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK