BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3351885 · Received September 13, 2013

    Report

    Report Number
    1217183-2013-00014
    Event Type
    Death
    Date Received
    September 13, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA BACK-UP FROM THE ACL TOP 500 LOCATED AT (B)(6) WAS REVIEWED WITH THE FOLLOWING CONCLUSIONS: THERE WERE NO INSTRUMENT MALFUNCTIONS REPORTED BY THE ANALYZER IN THE GENERAL LOG DURING THE TIME PERIOD OF THE EVENTS SPECIFIED IN THIS REPORT. THE NORMAL AND HIGH ABNORMAL CONTROLS FOR PT-RP RUN BEFORE AND AFTER THE EVENTS FOCUSED ON IN THIS REPORT WERE WITHIN ACCEPTABLE RANGE. THERE WERE A VARIETY OF NORMAL AND ABNORMAL PT-RP PATIENT RESULTS REPORTED BY THE INSTRUMENT BEFORE AND AFTER THE EVENTS FOCUSED ON IN THIS REPORT. ALL RESULTS WERE REVIEWED AND REPORTED PROPERLY BY THE INSTRUMENT. ALL RESULTS INVOLVED IN THE COMPLAINT REPORTED AS EXPECTED AND INSTRUMENT PERFORMED PROPERLY. THE CUSTOMER REPORTING OF THE 89.3 SECOND PT RESULT ON THE PATIENT SAMPLE IS IN ALIGNMENT WITH THE (B)(4) SECOND SAMPLE SEEN WHEN THE CLOT CURVES WERE REVIEWED AT (B)(4). THERE IS NO INDICATION THAT OUR INSTRUMENT WAS INVOLVED IN THE PATIENT DEATH.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FAILED PT RESULTS ON THEIR ACL TOP 500 CTS COAGULATION ANALYZER. CUSTOMER QUESTIONED THE HANDLING OF THE PT CLOT CURVES AND REPORTING OF FAILED RESULTS. THEY INDICATED THAT AN IL SPECIALIST ADVISED THEM THAT THEY CAN VIEW THE CURVE ON THE INSTRUMENT AND HOVER OVER THE DERIVATIVE PEAK OF THE CLOT CURVE TO SEE THE VALUE. THE IL SPECIALIST ALSO ADVISED THE CUSTOMER TO FOLLOW THEIR LAB PROTOCOL ON HANDLING OF FAILED RESULTS. THE CUSTOMER INDICATED THAT THERE IS NO SUCH PROTOCOL IN THEIR LABORATORY. SUBSEQUENTLY, THE CUSTOMER ELECTED TO REVIEW THE PT CURVE ON A SAMPLE FOR WHICH THE INSTRUMENT REPORTED A RESULT AS "FAILED." THEY ESTIMATED THE PT VALUE TO BE 89.3 SECONDS BY HOVERING OVER THE DERIVATIVE PEAK OF THE CLOT CURVE. THERE IS NO INDICATION THAT THE PT RESULT OF 89.3 SECONDS WAS LINKED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463070 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death