BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL VON WILLEBRAND FACTOR ACTIVITY

    MDR report key: 2513240 · Received March 20, 2012

    Report

    Report Number
    1217183-2012-00003
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    November 15, 2011
    Report Date
    March 20, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GGP
    PMA / PMN Number
    K040843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACH IS A SYNOPSIS OF THE TESTING TO DATE AND THE INVESTIGATION THAT IS ON-GOING AT THE CONTRACT MFR, BIOKIT. A FOLLOW-UP REPORT WILL BE FILED AS SOON AS THE CONCLUSION AND RISK ASSESSMENT ARE FINALIZED. CONCLUSION: A REVIEW OF THE DIFFERENCE BETWEEN COLUMNS B AND C AS WELL AS THE RATIOS IN COLUMNS D AND E INDICATES THAT THERE ARE SOME SAMPLES FOR WHICH INCUBATION WITH BOVINE IGG CAUSED THE VWF ACTIVITY RESULT AND THUS THE RATIO TO DECREASE, WHICH SUGGESTS THE PRESENCE OF HABIA IN THESE PT SAMPLES. STATUS: BIOKIT IS CURRENTLY PERFORMING FURTHER INVESTIGATION OF THE REAGENT.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THE NUMBER OF VWF ACTIVITY TO VWF ANTIGEN RATIOS HAS BEEN INCREASING. TOO MANY RATIOS ARE GREATER THAN 1.5.

    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 B11655

    Patients

    Seq Age Sex Outcome Treatment
    1