BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 2161692 · Received March 24, 2011

    Report

    Report Number
    3002807968-2011-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL DISTRIBUTOR PERFORMED A FULL SERVICE CHECK AND CHANGED A DEFECTIVE MEASURING CHAMBER. THE FALSE PCO2 RESULTS WERE CAUSED BY A LEAK IN THE MEASURING CHAMBER. THE HOSPITAL STAFF PERFORMED FREQUENT CALIBRATIONS AND QC'S TO BYPASS THE UNSTABLE PC02 MEASUREMENT, INSTEAD OF CORRECTING THE ROOT CAUSE. THE DEPARTMENT FOR CLINICAL BIOCHEMISTRY HAS AGREED TO PROACTIVELY DEAL WITH ANY INSTRUMENT ISSUES UNTIL THE HOSPITAL STAFF HAVE RECEIVED PROPER RETRAINING.

    Description of Event or Problem · 1

    THE PATIENT HAD COPD AND WAS PREVIOUSLY IN INTUBATED VENTILATION. HE WAS PUT IN NON INVASIVE VENTILATION (NIV) BECAUSE OF ERRONEOUS PCO2 RESULTS FROM THE ANALYZER. THERE WAS NO ERROR ON THE PREVIOUS QC RESULT. CALIBRATION RESULTS FOR PCO2 FROM THE LAST 19 HOURS SHOWED ERRORS FOR DRIFT, AND GAVE WARNINGS ON PATIENT RESULTS. THE LAST CALIBRATION BEFORE THE MEASUREMENT WAS OK, AND THUS THERE WERE NO WARNINGS ON THE REPORTED ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL800 FLEX BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL800 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR