BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800

    MDR report key: 2190527 · Received January 11, 2007

    Report

    Report Number
    3002807968-2007-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 22, 2006
    Report Date
    January 11, 2007
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K043218
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE HAS BEEN CORRECTED AND A FIELD ACTION TO CONDUCT A SOFTWARE UPGRADE AT RELEVANT CUSTOMERS HAS BEEN INITIATED. THE PROBLEM WILL BE SOLVED BY THE SOFTWARE UPGRADE.

    Description of Event or Problem · 1

    FOR (B)(4) FLEX BLOOD GAS ANALYZERS USING THE FLEXQ MODULE WE HAVE IDENTIFIED A PROBLEM IN THE SOFTWARE, WHICH MAY CAUSE RESULTS TO BE HANDLED INCORRECTLY. IN CASES WHERE A SAMPLE IS REGISTERED IN PRE-REGISTRATION MODE AND ANOTHER PT LOG AFTERWARDS IS OPENED, EDITED AND ACCEPTED, THE DEMOGRAPHIC DATA OF THE EDITED PT LOG WILL BE OVERWRITTEN WITH THE DATA FROM THE PRE-REGISTERED SAMPLE. THIS MAY RESULT IN PT MIX-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL800 ABL800 SERIES CHL RADIOMETER MEDICAL APS ABL825 NA

    Patients

    Seq Age Sex Outcome Treatment
    1