BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 6856196 · Received September 11, 2017

    Report

    Report Number
    1217183-2017-00003
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 14, 2017
    Report Date
    September 11, 2017
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    UDI-DI
    08426950453499
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WERE APPROPRIATELY DETERMINED BY THE ANALYZER AND THE INSTRUMENT WAS PERFORMING AS INTENDED. NOTE: A REVIEW OF THE INSTRUMENT SERVICE REPORT FROM THE DATE OF THE INCIDENT INDICATES THE CUSTOMER'S USE OF WASHED CUVETTES ON THE INSTRUMENT, WHICH IS NOT RECOMMENDED . 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 ON-BOARD STABILITY OF MATERIALS USED, THE USE OF WASHED CUVETTES, 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 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. OF THE 41 AFFECTED PATIENT SAMPLES, FIFTEEN TO TWENTY PATIENTS WERE ADMINISTERED UNNECESSARY BOLUSES OF HEPARIN DUE TO RESULTS BEING LOWER THAN EXPECTED. ALL FORTY-ONE SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635570 ACL TOP 500 CTS ACL TOP GKP INSTRUMENTATION LABORATORY 2800-40 08426950453499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other