BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 550 CTS

    MDR report key: 8383931 · Received March 1, 2019

    Report

    Report Number
    1217183-2019-00003
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    February 9, 2019
    Report Date
    March 1, 2019
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    UDI-DI
    08426950729242
    PMA / PMN Number
    K150877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED THAT INCLUDED REVIEW OF THE INSTRUMENT APTT CLOT CURVES ALONG WITH THE VERIFICATION OF SAMPLE AND REAGENT FLUIDIC PRECISION. APTT QUALITY CONTROL WAS WITHIN PASSING CRITERIA PRIOR TO PATIENT TESTING AND IMMEDIATELY AFTER THE QUESTIONABLE RESULTS WERE GENERATED. THE CONCLUSION IS THAT THE ACL TOP 550 CTS 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 550 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. THREE PATIENTS WERE ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULTS. THE APTT RESULTS WERE LATER CORRECTED AND THE HEPARIN DOSES WERE ADJUSTED AS APPROPRIATE. AFTER THE ADDITIONAL DOSE OF HEPARIN, THE PATIENTS WERE MONITORED AND THERE WERE NO COMPLICATIONS FROM THE ADDITIONAL HEPARIN ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174915 ACL TOP 550 CTS INSTRUMENT, COAGULATION, AUTOMATED GKP INSTRUMENTATION LABORATORY 2800-45 08426950729242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other