BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3495653 · Received November 22, 2013

    Report

    Report Number
    1217183-2013-00015
    Event Type
    Death
    Date Received
    November 22, 2013
    Date of Event
    September 1, 2013
    Report Date
    October 25, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ORIGINAL COMMUNICATION ON (B)(4) 2013, THE LAB SUPERVISOR, AGREED THAT A COMPLAINT NEEDED TO BE OPENED CONCERNING THE INCIDENT. WE REQUESTED INFO FROM THEM ON WHETHER THE INSTRUMENT WAS IN CLINICAL USE AT THE TIME OF THE EVENT, IF THE APTT RESULT IMPACTED PT THERAPY AND REQUESTED THAT THEY PROVIDE A DATA BACK-UP FROM THE INSTRUMENT. IN A F/U COMMUNICATION WITH AN IL FIELD REP, THE CUSTOMER INDICATED THAT THEY WANTED THE COMPLAINT INVESTIGATION STOPPED. THE CUSTOMER WILL NOT BE PROVIDING A DATA BACK-UP FROM THE INSTRUMENT AND INDICATED NO FURTHER INFO WOULD BE FORTHCOMING. BASED ON THE ABOVE, FURTHER INVESTIGATION IS NOT POSSIBLE BY INSTRUMENTATION LAB. NOTE: DIFFERENT FORMULATIONS OF APTT REAGENT CAN GENERATE DIFFERENT RESULTS AND SO COMPARISON OF THE TWO VALUES PRESENTED IS NOT MEANINGFUL. INTERPRETATION OF THE RESULTS CAN ONLY BE MADE RELATIVE TO EACH PRODUCT'S REP REFERENCE RANGE, AND IN THE CASE OF A HEPARINIZED PT, THE HEPARIN RESPONSE CURVE FOR THE PARTICULAR LOT OF REAGENT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE CUSTOMER REPORTED AN EVENT FROM (B)(6) 2013 TO INSTRUMENTATION LAB. ACCORDING TO THE CUSTOMER, A PT WITH RENAL FAILURE BLED TO DEATH. PHYSICIANS AT THE FACILITY WERE INQUIRING AS TO HOW TO PREVENT SUCH EVENTS FROM OCCURRING IN THE FUTURE. THE CUSTOMER VERBALLY STATED THAT THE ACL TOP 500 CTS IN USE AT THE TIME CORRECTLY REPORTED AN APTT RESULT OF 46 SECONDS OF APTT. THE CUSTOMER ALSO PERFORMED AN APTT ASSAY ON THEIR STAGO, WHICH REPORTED A RESULT OF 30 SECONDS. THE CUSTOMER ALSO INDICATED THAT MULTIPLE PTS WERE INVOLVED, BUT THAT ONLY ONE HAD EXPIRED. THERE WAS NO INDICATION THAT THE ACL TOP 500 CTS MALFUNCTIONED OR WAS INVOLVED IN THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607959 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Death