BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL VON WILLEBRAND FACTOR ACTIVITY

    MDR report key: 2593701 · Received May 24, 2012

    Report

    Report Number
    1217183-2012-00007
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    March 23, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT TREATMENT OR ADVERSE EVENTS WERE INVOLVED WITH THIS COMPLAINT. FURTHER, IL MAKES NO CLAIM FOR PERFORMANCE OF THIS REAGENT ON A NON-IL ANALYZER WHICH THE CUSTOMER WAS USING.

    Description of Event or Problem · 1

    THE CUSTOMER, WHO USES A STA ANALYZER, REPORTED THAT "FOR ALMOST THE PAST 3 WEEKS NOW, WE HAVE BEEN TROUBLESHOOTING THE RISTOCETIN COFACTOR ASSAY USING THE HEMOSIL VWF REAGENT LOT B11498, EXP 7/31/2012. ACCORDING TO THE CUSTOMER, THERE APPEARS TO BE A SHIFT OF SOME SORT WITH THE REAGENT. THE NORMAL RANGE FOR THE NORMAL CONTROL IS 67-91%, BUT THE CUSTOMER IS RECOVERING MUCH HIGHER RESULTS. ALSO THEY ARE RECOVERING MUCH HIGHER RESULTS FOR OTHER KNOWN ASSAY MATERIALS.

    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