BEUDAMED
    FDA Adverse Event Death Summary report: N

    IL TEST PT-FIBRINOGEN

    MDR report key: 346571 · Received August 9, 2001

    Report

    Report Number
    2431530-2001-00001
    Event Type
    Death
    Date Received
    August 9, 2001
    Report Date
    August 8, 2001
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GIS
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT TEXT FROM THE BECKMAN COULTER (PRODUCT DISTRIBUTOR), CUSTOMER ENTERED INCORRECT ISI VALUE INTO IN-HOUSE COMPUTER SYSTEM RESULTING IN ERRONEOUS INR RESULTS AND CONSEQUENTLY, ERRONEOUS PT RESULTS (N = 932). THE REAGENT USED, IL TEST PT-FIBRINOGEN, PART NO. 09756710, LOT NO. N0216690, EXP. IN 2004, WAS CORRECTLY LABELED WITH AN ISI VALUE OF 2.082. HOWEVER, THE CUSTOMER MISTAKENLY ENTERED AN ISI VALUE OF 1.0 IN THEIR IN-HOUSE COMPUTER SYSTEM INSTEAD OF USING THE LOT-SPECIFIC ISI VALUE OF 2.082 PUBLISHED IN THE PRODUCT INSERT. THE COAGULATION INSTRUMENTS USED AT THE SITE WERE AN ACL 1000 AND ACL 3000; HOWEVER, THE INR RESULTS WERE CALCULATED USING AND IN-HOUSE COMPUTER SYSTEM, NOT FROM THE INSTRUMENTS. IN ADDITION TO THE PRODUCT LABELING, A SUPPLEMENTAL NOTICE ADVISING OF THE IMPORTANCE OF THE ISI VALUES (WHICH CHANGE WITH NEW REAGENT LOTS) IN REPORTING ACCURATE PT RESULTS WAS SENT TO ALL IL ACL COAGULATION ANALYZER CUSTOMERS (ACL MODEL SERIES: 100-7000) AND THIS SITE CONFIRMED RECEIPT OF THE NOTIFICATION ON 10/10/00. NOTE: ALTHOUGH NOT REPORTED IN THE COMPLAINT TEXT, THERE HAVE BEEN NUMEROUS NEWS REPORTS OF POSSIBLE DEATHS RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35914 IL TEST PT-FIBRINOGEN PROTHROMBIN TIME AND FIBRINOGEN TEST SYSTEM GIS INSTRUMENTATION LABORATORY CO. NA N0126690

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN