BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2192897 · Received July 25, 2011

    Report

    Report Number
    1181121-2011-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Report Date
    July 21, 2011
    Product Code
    GHH
    PMA / PMN Number
    K920668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO INCIDENTS OF ACTUAL ADVERSE EVENTS HAVE BEEN REPORTED AT THIS TIME. THE MANUFACTURER (B)(6) OF THIS DEVICE NOTIFIED FISHER DIAGNOSTICS OF A SUSPECTED PERFORMANCE FAILURE. MINUTEX D-DIMER IS A MANUAL VISUAL LATEX AGGLUTINATION TEST. INTERNAL INVESTIGATION AT (B)(6) STATED THAT THE DEVICE MAY FAIL TO PERFORM WITHIN THE INTERNAL SPECIFICATIONS AND STATED CLAIMS ON THE PACK INSERT. THE SENSITIVITY SPECIFICATION IS 175 - 275 NG/ML, AND IS NOW ESTIMATED AT 654 NG/ML. (B)(4) MANUFACTURES THIS DEVICE HOWEVER IT IS SOLD AS PACIFIC HEMOSTASIS D-DIMER ASSAY KIT (CATALOG # 100659, 100660). THIS MALFUNCTION COULD RESULT IN INCREASED RISK OF FALSE (B)(6) IN DIAGNOSIS OF VENOUS THROMBOEBOLIC DISEASE, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), PRE-ECLAMPSIA OR ECLAMPSIA. OF THESE DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM BEING THE HIGHEST RISK HAVING A FALSE (B)(6) BECAUSE APPROPRIATE TREATMENT MAY NOT BE INITIATED. ALL TESTING TO CONFIRM THE DEVICE MALFUNCTION HAS BEEN CONDUCTED AT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GHH

    Patients

    Seq Age Sex Outcome Treatment
    1