BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIANCE

    MDR report key: 2456344 · Received February 10, 2012

    Report

    Report Number
    3002807968-2012-00004
    Event Type
    Other
    Date Received
    February 10, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 11, 2012
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CIG
    PMA / PMN Number
    K050869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED INCORRECT BLOOD GAS SAMPLE RESULTS TO A PHYSICIAN BECAUSE HE HAD MANUALLY ALTERED THE ANALYZED TIME TO A PREVIOUS SAMPLE'S ANALYZED TIME IN THE SYSTEM. THE PT WAS WITHHELD TREATMENT BASED ON PREVIOUS SAMPLE RESULTS RATHER THAN THE MOST CURRENT SAMPLE RESULTS AND HIS PH LEVEL DROPPED TO A DANGEROUS LEVEL OF 7.175. THE PT GOT A SEVERE RESPIRATORY ACIDOSIS WITH HYPOXEMIA. THE PT WAS ADMINISTER TREATMENT THE FOLLOWING DAY AFTER ANOTHER BLOOD GAS WAS DRAWN SHOWING THE DANGEROUS LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE RADIANCE VERSION 2.74 CIG RADIOMETER MEDICAL APS V.2.74

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening