BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL ADVANCE

    MDR report key: 669419 · Received January 27, 2006

    Report

    Report Number
    1217183-2006-00001
    Event Type
    Death
    Date Received
    January 27, 2006
    Report Date
    January 26, 2006
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ACL ADVANCE IN USE AT THE TIME OF THIS INCIDENT WAS NOT DIRECTLY RESPONSIBLE FOR THE ADVERSE EVENT. THE INCIDENT WAS A CUSTOMER EDUCATION ISSUE. CUSTOMER COMPLAINT RECEIVED THAT INDICATED THEY WERE UNABLE TO OBTAIN PT/APTT RESULTS WITH THEIR ACL ADVANCE ON A PT, DUE TO POSSIBLE LOW FIBRINOGEN. OUR REVIEW SHOWED THAT THE PT SAMPLE RESULTS WERE BOTH FLAGGED WITH A "COAG ERROR 8"; HOWEVER, THE CUSTOMER STILL REPORTED OUT THE RESULTS (GREATER THAN 100 SECONDS FOR PT AND GREATER THAN 150 SECONDS FOR APTT). THE PT WAS "DO NOT RESUSCITATE" AND DIED THAT DAY. HOWEVER, PER THE CUSTOMER, THE PT'S DEATH WAS NOT A DIRECT RESULT OF INCORRECT RESULTS FROM THE ACL ADVANCE. BACKUP DISKS FROM THE INSTRUMENT WERE UNAVAILABLE AS DATABASE MAINTENANCE WAS PERFORMED BY THE CUSTOMER, PRIOR TO NOTIFICATION OF THE COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *