BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL TOP CTS

    MDR report key: 1512560 · Received October 16, 2009

    Report

    Report Number
    1217183-2009-00003
    Event Type
    Death
    Date Received
    October 16, 2009
    Date of Event
    September 3, 2009
    Report Date
    October 16, 2009
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    PMA / PMN Number
    K073377
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN IL INVESTIGATION IS CURRENTLY UNDERWAY REGARDING THIS COMPLAINT, AND THE ACL TOP BACKUP AND PRINTOUTS HAVE BEEN REQUESTED FROM THE CUSTOMER. ONCE THE INVESTIGATION IS COMPLETE, WE WILL SUBMIT A FOLLOW-UP REPORT WITH THE RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WITH AN APTT RESULT OF 89 SEC. HAD A CEREBRAL HEMORRHAGE. THE CUSTOMER WAS HAVING ISSUES WITH HEPARIN DOSAGE AND THEIR APTT HEPARIN RANGE. THEY HAD RECENTLY STARTED USING A NEW LOT OF HEMOSIL SYNTHASIL (APTT REAGENT) ON THEIR ACL TOP CTS (CLOSED TUBE SAMPLING) COAGULATION ANALYZER, AND THIS CHANGED THEIR HEPARIN RANGE SLIGHTLY FROM 65.0-120.0 SEC. TO 73.0-125.0 SEC. AFTER PERFORMING A HEPARIN RANGE STUDY. CUSTOMER ALSO REPORTED EXPERIENCING PTS THAT ARE ON HEPARIN AND THE APTT OF 31 SEC. AND THE ANTI-XA FOR UF IS 0.09. PER THE CUSTOMER, THEY ARE USING HOMEMADE QC MATERIAL FOR THE HEPARIN ASSAY. THEIR 0.3 QC GIVES A VALUE OF 0.28 AND THE 0.6 QC GIVES A VALUE OF 0.58. THEREFORE, THE ASSAY IS READING CORRECTLY. WHEN HEMOSIL SYNTHASIL WAS RUN ON THE ACL TOP CTS WITH THE HOMEMADE QC, THE RESULTS WERE 85 SEC. ON THE 0.3 QC AND > 150 SEC. ON THE 0.6 QC, WHICH ARE OUTSIDE THE ESTABLISHED RANGE. THERE WAS A QUESTION IF THEY COULD DO THIS BECAUSE THE QC MATERIAL IS NORMAL POOLED PLASMA SPIKED WITH HEPARIN AND THE RANGE WAS BASED ON ACTUAL PT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP CTS COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY CO. 2800-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death