BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 8956671 · Received September 3, 2019

    Report

    Report Number
    1217183-2019-00004
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 11, 2019
    Report Date
    September 3, 2019
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    UDI-DI
    08426950453499
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. IMMEDIATELY FOLLOWING PATIENT TESTING, APTT QUALITY CONTROL FAILED. THE APTT REAGENT VIAL WAS REPLACED AND QUALITY CONTROL RESULTS RECOVERED WITHIN ACCEPTABLE RANGE. THE PATIENTS IN QUESTION WERE REPEATED AND CORRECTED APTT REPORTS WERE GENERATED. BASED ON THE ABOVE, THE ACL TOP 500 CTS SYSTEM WAS PERFORMING WITHIN SPECIFICATION AND NO REMEDIAL ACTION IS NEEDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. FOUR PATIENTS HAD RESULTS THAT WERE CLINICALLY SIGNIFICANT AND NEEDED TO BE CORRECTED. ONE PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULT. THE APTT RESULT WAS LATER CORRECTED AND THE HEPARIN DOSE WAS ADJUSTED AS APPROPRIATE. THERE WERE NO KNOWN COMPLICATIONS TO THE PATIENT FROM THE ADDITIONAL HEPARIN ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749641 ACL TOP 500 CTS INSTRUMENT, COAGULATION, AUTOMATED, PRODUCT CODE: GKP GKP INSTRUMENTATION LABORATORY 2800-40 08426950453499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other