BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSTRUMENTATION LABORATORIES

    MDR report key: 286399 · Received July 18, 2000

    Report

    Report Number
    286399
    Event Type
    Death
    Date Received
    July 18, 2000
    Date of Event
    January 23, 2000
    Report Date
    June 21, 2000
    Manufacturer
    *
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 10/09/1999 BECKMAN COULTER TECH INSTALLED NEW SOFTWARE FOR Y2K PREPARATION FOR NOTED MACHINE. THE TECH FAILED TO PROPERLY INSTALL THE INR CALCULATION DEFAULT. SOFTWARE DID NOT IDENTIFY THIS ERROR AND GENERATED "TEST RESULTS". QUALITY CONTROL PERFORMED ON PT TEST VALUE RESULTS WERE CORRECT, THEREFORE CALCULATION ERROR NOT IDENTIFIED. MEDICAL STAFF WAS ADJUSTING COUMADIN DOSE ON THE ERRONEOUS INR, WHICH WAS UNDER REPORTING VALUES AND PTS WERE BEING OVERMEDICATED. ERROR IDENTIFIED 04/12/2000 AND CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENTATION LABORATORIES COAGULATION ANALYZER, AUTOMATED JPA * ACL200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death