BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL TOP CTS

    MDR report key: 3554555 · Received January 3, 2014

    Report

    Report Number
    1217183-2013-00020
    Event Type
    Other
    Date Received
    January 3, 2014
    Date of Event
    November 15, 2013
    Report Date
    December 20, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) 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 OUTPTS 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 ASSESMENT OR TRACKING OF A CANCER PT 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 FOLLOW UP REPORT WILL BE FILED WHEN TESTING HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER FILED COMPLAINT ON (B)(6) 2013. PT WHO HAD UNDERGONE SURGERY FOR BREAST CANCER TESTED FOR D DIMER IN DIFFERENT LABS, ALWAYS WITH RESULTS BEING NEGATIVE. WHEN THE TEST WAS PERFORMED AT SITE IN (B)(6), ON AN ACL TOP CTS WITH HEMOSIL D DIMER, THE RESULTS WERE ALWAYS POSITIVE. ON (B)(6) THE TEST WAS PERFORMED AT (B)(6). THE RESULT FAILED, AND THE TEST WAS AUTOMATICALLY RE-RUN. THE RESULT WAS POSITIVE. THE CHIEF OF THE LABORATORY WAS EXPECTING A POSITIVE RESULT FOR D DIMER BECAUSE OF THE CLINICAL HISTORY OF THE PT, WHICH INCLUDED HER BREAST CANCER, AND THE FACT THAT SHE NOW HAS SILICONE BREAST IMPLANTS. BECAUSE OF THE DIFFERENCE BETWEEN THE POSITIVE RESULTS AT HIS LABORATORY AND THE NEGATIVE RESULTS OBTAINED BY ANOTHER LAB, THE DOCTOR DECIDED TO PERFORM THE TEST ON TWO DIFFERENT SYSTEMS: THE ACL ACUSTAR AND SYSMEX CA 7000, LOCATED AT A DIFFERENT HOSPITAL. THE CUSTOMER IS QUESTIONING THE POSITIVE RESULTS GIVEN BY THE ACL TOP CTS AND SYSMEX CA7000 VERSUS THE NEGATIVE GIVEN BY THE ACL ACUSTAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3846 ACL TOP CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-20

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR