BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIAISON TREPONEMA ASSAY

    MDR report key: 3082583 · Received April 8, 2013

    Report

    Report Number
    9610240-2013-00001
    Event Type
    Other
    Date Received
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    LIP
    PMA / PMN Number
    K061247
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DIASORIN'S INVESTIGATION DETERMINED THAT THE LIAISON TREPONEMA ASSAY, CATALOG NUMBER 310480, LOT NUMBER 113025X/1 MEETS ASSAY PERFORMANCE REQUIREMENTS FOR NEGATIVE AGREEMENT AND EXPECTED FALSE POSITIVES AS STATED WITHIN THE IFU WHEN USING THE REVERSE SEQUENCE SYPHILIS SCREENING ALGORITHM ACCORDING TO THE CDC MMWR FROM FEBRUARY 11, 2011 (DISCORDANT RESULTS FROM REVERSE SEQUENCE (B)(6) SCREENING, FIVE LABORATORIES, UNITED STATES, 2006-2010, MMWR (B)(4) 2011; (B)(4)). THE PRODUCT CONTINUES TO PERFORM CONSISTENT WITH ITS PUBLISHED PERFORMANCE SPECIFICATIONS. DIASORIN CONCLUDES THAT THERE HAS BEEN NO PRODUCT MALFUNCTION NOR DEATH OR SERIOUS INJURY WHICH CAN BE ATTRIBUTED TO THE USE OF THE LIAISON TREPONEMA ASSAY.

    Description of Event or Problem · 1

    SEE USER MEDWATCH FORM, UF/IMPORTER REPORT # (B)(4). DIASORIN INC. REC'D A COMPLAINT FROM (B)(6) 2012 REGARDING THE DIASORIN LIAISON TREPONEMA ASSAY, CATALOG NUMBER 310480. THE LIAISON TREPONEMA ASSAY USES CHEMILUMINESCENT IMMUNOASSAY (CLIA) TECHNOLOGY ON THE LIAISON ANALYZER FAMILY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES DIRECTED AGAINST TREPONEMA PALLIDUM IN HUMAN SERUM. THE PRESENCE OF ANTIBODIES TO TREPONEMA PALLIDUM SPECIFIC ANTIGEN, IN CONJUNCTION WITH NON TREPONEMAL LABORATORY TESTS AND CLINICAL FINDINGS MAY AID IN THE DIAGNOSIS OF (B)(6) INFECTION. THE COMPLAINT ALLEGED AN INCREASED NUMBER OF REACTIVE SAMPLES IN THE RESULT UPON RESOLUTION WITH RPR AND TP-PA WERE NEGATIVE. THE LOT NUMBER IN QUESTION IS 113025X/1 A SUB LOT OF 113025X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143013 LIAISON TREPONEMA ASSAY LIP DIASORIN S.P.A. 113025X

    Patients

    Seq Age Sex Outcome Treatment
    1