BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN SYCRON

    MDR report key: 66405 · Received December 31, 1996

    Report

    Report Number
    66405
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    October 13, 1996
    Report Date
    October 31, 1996
    Manufacturer
    BECKMAN INSTRUMENTS
    Product Code
    JJC
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    OIR ERROR MESSAGE CHANGED FROM LO OIR/HI OIR-TROUBLE SHOOTING MISLEADING. TECHNICAL ASSISTANT CHECK ABS-PROCEDURE UNCLEAR-USED INCORRECTLY. 4.0 SOFTWARE CHANGES CHANGED FORMAT. NO LONGER HI/LO OIR. DILUTION PROTOCOL INSTITUTED TO ELIMINATE PROBLEM. CHANGE IN SOFTWARE ADEQUATE NOTIFICATION AS TO CHANGES IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN SYCRON CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS CX-4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention