BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL TOP 500 CTS

    MDR report key: 2104044 · Received May 12, 2011

    Report

    Report Number
    1217183-2011-00007
    Event Type
    Death
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 12, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INSTRUMENT MALFUNCTION INVOLVED IN THIS INCIDENT. THE ACL TOP 500 CTS INSTRUMENT APPROPRIATELY FLAGGED THE SAMPLE AS "FAILED", WITH NO PT RESULT REPORTED. THE CUSTOMER CONFIRMS THAT THE REPORTED PT RESULT WAS DUE TO AN OPERATOR ERROR. THERE IS NO INDICATION FROM THE CUSTOMER THAT THE ERRONEOUS PT RESULTS WAS INVOLVED IN PT TREATMENT OR CONTRIBUTED TO THE SUBSEQUENT DEATH. NO REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 1

    CUSTOMER NOTIFIED US THAT AN INEXPERIENCED OPERATOR IGNORED A "FAILED" RESULT (NO PT VALUE REPORTED BY THE ANALYZER) ON THEIR ACL TOP 500 CTS ANALYZER. DESPITE THE INSTRUMENT NOT REPORTING A RESULT AND FLAGGING THE SAMPLE AS "FAILED" ON BOTH THE PRINTOUT AND SCREEN, THE OPERATOR DECIDED TO VISUALLY REVIEW THE CLOT CURVE AND ERRONEOUSLY MISINTERPRETED A PEAK AT THE CURVE BASELINE AS A PT RESULT OF 13.6 SECONDS. THE RESULT OF 13.6 SECONDS WAS THEN REPORTED TO THE PHYSICIAN. THE NEXT DAY A SUPERVISOR CAUGHT THE OPERATOR'S ERROR. HOWEVER, NO ACTION WAS TAKEN SINCE THE PT HAD PASSED AWAY. IT WAS NOTED BY THE CUSTOMER THAT A CORRECT PT RESULT FROM A LATER BLOOD DRAW HAD BEEN REPORTED TO THE PHYSICIAN. NOTE: THE PT IN QUESTION WAS ADMITTED TO THE HOSPITAL DUE TO A TYLENOL OVERDOSE AND SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1