BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP CTS

    MDR report key: 6880325 · Received September 20, 2017

    Report

    Report Number
    1217183-2017-00004
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    August 22, 2017
    Report Date
    September 20, 2017
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED THAT INCLUDED A REVIEW OF THE INSTRUMENT DATA. REVIEW OF THE DATA CONCLUDED THAT THE VALUES OBTAINED ON THE ACL TOP WERE APPROPRIATELY DETERMINED BY THE ANALYZER AND THE INSTRUMENT WAS PERFORMING AS INTENDED. WHILE THE ROOT CASE CANNOT BE DETERMINED, THERE ARE MANY VARIABLES THAT HAVE THE POTENTIAL TO INFLUENCE THE RESULT RECOVERIES. THESE MAY INCLUDE, BUT NOT LIMITED TO, THE ACCURACY OF THE RECONSTITUTION OF THE REAGENTS AND CLEANING MATERIALS USED, THE ONBOARD STABILITY OF MATERIALS USED, REAGENT AND/OR SAMPLE HANDLING, AND SAMPLE INTEGRITY ALL OF WHICH COULD HAVE CONTRIBUTED TO THE GENERATED FINDINGS. BASED ON THE ABOVE, THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION AND NO REMEDIAL ACTION IS NEEDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR ACL TOP CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. THIRTEEN SAMPLES GENERATED ERRONEOUS RESULTS. ONE PATIENT WAS ADMINISTERED AN UNNECESSARY BOLUS OF HEPARIN DUE TO THE APTT RESULT BEING LOWER THAN EXPECTED. ALL THIRTEEN SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659373 ACL TOP CTS ACL TOP GKP INSTRUMENTATION LABORATORY 2800-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other