BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL 2000/ANTI-THROMBIN III

    MDR report key: 32178 · Received March 4, 1996

    Report

    Report Number
    67955-1996-09001
    Event Type
    Death
    Date Received
    March 4, 1996
    Report Date
    February 27, 1996
    Manufacturer
    INSTRUMENTATION LABORATORIES
    Product Code
    JPE
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WAS TREATED BASED ON ERRONEOUS RESULTS FROM DEVICE. A VALUE OF 139% AND 180%; BASED ON A "LINEARITY" RANGE OF 0-150%, RESULTS WERE REPORTED. HOWEVER, THE SPECIFIED RANGE FOR DEVICE IS 0-120%; THE FLAGGING RANGE FOR THE UNIT (0-150%) WAS MISTAKEN FOR REAGENT LINEARITY. ALTHOUGH CUSTOMER INITIALLY REFUSED TO RELEASE INFO ON PT CONDITION, THEY LATER ADVISED THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL 2000/ANTI-THROMBIN III COAGULATION INSTRUMENTATION & REAGENTS JPE INSTRUMENTATION LABORATORIES 106 951016

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death