BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME

    MDR report key: 2003540 · Received February 23, 2011

    Report

    Report Number
    MW5019527
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    March 1, 2010
    Report Date
    February 14, 2011
    Product Code
    GFO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BECKMAN-COULTER HEMOSIL SILICA CLOTTING TIME (PART NUMBER (B)(4)). TEST IS USED AS PART OF TESTING PANEL FOR PRESENCE OF LUPUS ANTICOAGULANT. THERE IS VARIATION IN THE LOTS OF REAGENTS IN THAT SOME LOTS HAVE MUCH HIGHER POSITIVITY RATES (USUALLY EXPECT 15% OF THE TESTED POPULATION, WITH CERTAIN LOTS AS HIGH AS 45%). TWO POSITIVES OVER 10 TO 12 WEEKS ARE FELT TO BE INDICATIVE OF LUPUS ANTICOAGULANT. PATIENTS MAY RECEIVE TREATMENT FOR PREVENTION OF THROMBOSIS SUCH AS COUMADIN (WITH INCREASED BLEEDING AS A POTENTIAL COMPLICATION) OR OTHER INTERVENTIONS AS INFERIOR VENA CAVA BALLOON. IN SUMMARY, VARIATION FROM LOT TO LOT OF REAGENTS MEAN THAT THERE ARE PROBABLY SIGNIFICANTLY INCREASED FALSE POSITIVES WITH CERTAIN REAGENT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME SILICA CLOTTING TIME GFO N0301827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other