BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL VON WILLEBRAND FACTOR ACTIVITY

    MDR report key: 2593700 · Received May 24, 2012

    Report

    Report Number
    1217183-2012-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    April 16, 2012
    Report Date
    May 24, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GGP
    PMA / PMN Number
    K040843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT LOT NUMBER, B11498, IS UNDER RECALL ACTION AND IS ON FILE WITH THE FDA AS A CLASS II ACTION (REFERENCE Z-1519-2012). THE CUSTOMER HAD NOT RECEIVED THE RECALL NOTIFICATION AT THE TIME OF THE INCIDENT AND HAS SINCE RECEIVED THE NOTIFICATION AND FOLLOWED THE NECESSARY ACTIONS. PER THE CUSTOMER, NO PT TREATMENT OR ADVERSE EVENTS WERE INVOLVED WITH THIS COMPLAINT. FURTHER, (B)(4) MAKES NO CLAIM FOR PERFORMANCE OF THIS REAGENT ON A NON-IL ANALYZER WHICH THE CUSTOMER WAS USING.

    Description of Event or Problem · 1

    CUSTOMER STATED THEY ARE A REFERENCE LAB USING A STA-R EVOLUTION INSTRUMENT WITH VWF ACTIVITY PART NUMBER 20004700, LOT B11498. THEY HAVE 4 SAMPLES THAT WERE VERIFIED AS ERRONEOUS BY AN ALTERNATE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSIL VON WILLEBRAND FACTOR ACTIVITY FACTOR DEFICIENCY TEST GGP INSTRUMENTATION LABORATORY CO. NA B11498

    Patients

    Seq Age Sex Outcome Treatment
    1