BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL TOP CTS

    MDR report key: 3556934 · Received December 24, 2013

    Report

    Report Number
    1217183-2013-00023
    Event Type
    Other
    Date Received
    December 24, 2013
    Date of Event
    November 25, 2013
    Report Date
    December 20, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEMOSIL D DIMER IS AN AUTOMATED LATEX ENHANCED IMMUNOASSAY INTENDED FOR THE QUANTITATIVE DETERMINATION OF D DIMER IN HUMAN CITRATED PLASMA ON IL COAGULATION SYSTEMS FOR USE IN CONJUNCTION WITH A CLINICAL PRE-TEST PROBABILITY ASSESSMENT MODEL TO EXCLUDE VTE IN OUTPATIENTS SUSPECTED OF DVT AND PE. HEMOSIL ACUSTAR D DIMER IS A FULLY AUTOMATED CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF D DIMER IN HUMAN CITRATED PLASMA ON THE ACL ACUSTAR AS AN AID IN THE DIAGNOSIS OF VENOUS THROMBOEMBOLISM AND PULMONARY EMBOLISM. THESE PRODUCTS MAKE NO CLAIM FOR THE ASSESSMENT OR TRACKING OF OTHER DISEASES AND USE OF THE PRODUCT IN SUCH A WAY CONSTITUTES OFF LABEL USE. REAGENTS AND SAMPLES WILL BE OBTAINED TO PURSUE TESTING TO INVESTIGATE THE REPORTED DISCREPANCY BETWEEN THE IL METHODS. A F/U REPORT WILL BE FILED WHEN TESTING HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A FEMALE PT (B)(6) WAS BEING TESTED FOR D DIMER. THE TESTS WERE PERFORMED MULTIPLE TIMES SINCE 2012 ON AN ACL FUTURA AND ON THE ACL TOP CTS USING HEMOSIL D DIMER. BOTH INSTRUMENTS REPORTED POSITIVE RESULTS. THE PT WAS TESTED IN ANOTHER CENTER ON A DIFFERENT INSTRUMENT (SYSMEX CA7000), AND THE RESULTS WERE POSITIVE ON TWO OCCASIONS, AND NEGATIVE ON THE THIRD. THE SAMPLES WERE ALSO TESTED ON AN ACL ACUSTAR, AND THE RESULTS WERE ALWAYS NEGATIVE. ON (B)(6) 2013 WHILE THE PT WAS IN THE EMERGENCY ROOM, D DIMER WAS TESTED AND A POSITIVE RESULT WAS REPORTED. THE PT WAS GIVEN HEPARIN THERAPY. THE CUSTOMER IS QUESTIONING THE APPROPRIATENESS OF THIS TREATMENT. THERE IS NO INFO AS TO WHETHER AN ECHO DOPPLER WAS RUN, OR ANY OTHER TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674530 ACL TOP CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-20

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR