BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA LABORATORY INFORMATION SYSTEM

    MDR report key: 1076537 · Received July 11, 2008

    Report

    Report Number
    9615148-2008-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 12, 2008
    Manufacturer
    GE HEALTHCARE INFORMATION TECHNOLOGIES
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUI PATCH 3.3.2.27_P4 WAS INSTALLED IN THE CLIENT'S PRODUCTION SYSTEM IN 2008 AND BACKED OUT SIX DAYS PRIOR. THE ISSUE WAS DETERMINED TO BE CAUSED BY A CODE ERROR. THE RANGE FLAG FOR NUMERIC RESULTS WERE INCORRECTLY OVERWRITTEN.

    Description of Event or Problem · 1

    THE CLIENT REPORTED THAT THE RESULT FLAG IS NOT BEING SENT ON RESULTS WITH LOW VALUES. ULTRA REPORTS ARE CORRECT AND ARE DISPLAYING THE CORRECT FLAGS; HOWEVER, THEY ARE NOT DISPLAYING WHEN SENT ELECTRONICALLY TO EXCELLERIS, A THIRD PARTY SOFTWARE. THE ISSUE STARTED TO OCCUR AFTER THE PATCH 3.3.2.27_P4 INSTALLED IN PRODUCTION IN 2008. THE CLIENT'S SQL RECORDS SHOWED THAT REQUESTS WERE SENT BETWEEN 6AM THE SAME MONTH. AS A RESULT OF THE LOW FLAGS NOT BEING TRANSMITTED IN THE MESSAGES, THE CLIENT HAD TO RETRANSMIT REQUESTS THREE DAYS LATER. ONCE THESE REQUESTS WERE RE-SENT TO EXCELLERIS, THE EXCELLERIS GROUP ALSO PERFORMED A SQL TO ONLY UPDATE REQUESTS HAVING LOW FLAGS WITH CHANGED STATUS. ALL REQUESTS HAD CHANGED STATUS. EXCELLERIS CLIENTS/RECIPIENTS WERE ALERTED REGARDING THE CORRECTED STATUS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA LABORATORY INFORMATION SYSTEM LABORATORY INFORMATION SYSTEM MMH GE HEALTHCARE INFORMATION TECHNOLOGIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA EXCELLERIS (HOSPITAL INFO SYSTEM)