BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN SYCRON

    MDR report key: 66408 · Received December 31, 1996

    Report

    Report Number
    66408
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    October 11, 1996
    Report Date
    October 31, 1996
    Manufacturer
    BECKMAN INSTRUMENTS
    Product Code
    JJC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CHANGE IN OIR ERROR MESSAGE FOR RESULTS OUT OF LINEARITY LED STAFF TO BELIEVE RESULTS TO BE BELOW LINEARITY WHEN IN FACT RESULTS WERE GREATER THE LINEARITY. PREVIOUS LO OIR/HI OIR MESSAGE WHEN OUT OF LINEARITY RESULTS WERE OBTAINED. 4.0 SOFTWARE CHANGED THIS. TROUBLE SHOOTING INFO NOT CLEAR TO RESOLVE ISSUE. TOLD TO CHECK ABS-FOUND THIS MISLEADING. DILUTION PROTOCOL INSTITUTED.

    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 40 YR Required Intervention