BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 8024101 · Received October 31, 2018

    Report

    Report Number
    1217183-2018-00009
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 31, 2018
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    UDI-DI
    08426950453499
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED THAT INCLUDED A REVIEW OF THE INSTRUMENT CLOT CURVES. ALL APTT RESULTS ILLUSTRATED WELL-FORMED CURVE FORMATION, WITH APPROPRIATE CLOTTING TIMES DETECTED AND NO CONCERNING ERRORS OR WARNINGS. THE CONCLUSION IS THAT THE VALUES OBTAINED ON THE ACL TOP 500 CTS WERE APPROPRIATELY DETERMINED BY THE ANALYZER AND THE INSTRUMENT WAS PERFORMING AS INTENDED. BASED ON THE ABOVE, THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION AND NO REMEDIAL ACTION IS NEEDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED AN ERRONEOUS APTT RESULT (36.9 SECONDS) USING HEMOSIL SYNTHASIL. A PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THIS ERRONEOUS APTT RESULT. SUBSEQUENTLY, ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT (APPROXIMATELY 3 HOURS LATER) AND IT REPORTED AN APTT RESULT OF > 200. THE HEPARIN ADMINISTRATION WAS STOPPED AND THE CUSTOMER INDICATED THAT THE PATIENT'S APTT RESULT WAS BROUGHT BACK INTO THE THERAPEUTIC RANGE. THERE WERE NO FURTHER REPORTS OF CLINICAL IMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864737 ACL TOP 500 CTS ACL TOP, PRODUCT CODE: GKP GKP INSTRUMENTATION LABORATORY 2800-40 08426950453499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other