BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL 700 SERIES

    MDR report key: 697796 · Received April 7, 2006

    Report

    Report Number
    3002807968-2006-00021
    Event Type
    Other
    Date Received
    April 7, 2006
    Date of Event
    February 24, 2006
    Report Date
    February 24, 2006
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THEY SOMETIMES MEASURES UNREALISTIC HIGH VALUES OF COHB AND THEREFORE THEY DO NOT USE THEIR MEASURMENTS FOR THIS PARAMETER. IN MOST PATIENTS, THE RESULTS FROM BLOOD GAZ ANALYSIS WILL BE CORRECT, BUT THERE ARE CASES WITH PATIENTS WHO HAS INCREASED DYSHEMOGLOBIN FRACTIONS, AND THEREFORE THE MEASURED VALUE CANNOT BE USED. THE PROBLEM IS DESCRIBED IN THE FOLLOWING ARTICLE: CLINICAL CHEMISTRY 51:2 434-444,2005 NO PREVIOUS EVENTS HAS BEEN DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL 700 SERIES BLOOD GAZ ANALYSIS CCE RADIOMETER MEDICAL APS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Congenital Anomaly