BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 3950811 · Received June 13, 2014

    Report

    Report Number
    3002807968-2014-00019
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 14, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER AFTER THE EVENT. THE FSE ANALYZED THE DATA LOGS AND OBSERVED THAT 2 SAMPLES FAILED ON 22ND OF APRIL DUE TO "NO LEADING AIR SEGMENT DETECTED" AND ONE SAMPLE FAILED DUE TO "INSUFFICIENT SAMPLE". WHILE ON SITE, HE RAN LIQUID SENSOR CALIBRATIONS, PUMP CALIBRATIONS, INLET CALIBRATIONS, 1 AND 2 POINT CALIBRATIONS, ALL OF WHICH RAN FINE. SINCE 22ND APRIL, A TOTAL OF (B)(4) FOETAL SAMPLES HAVE BEEN RUN, ALL OF WHICH HAVE RUN FINE. ACCORDING TO THE ABL800 FLEX OPERATORS MANUAL, CERTAIN STEPS MUST BE FOLLOWED TO ENSURE CORRECT SAMPLE HANDLING WHEN FETAL SCALP SAMPLES ARE TAKEN, AS THEY ARE GENERALLY REGARDED AS POTENTIALLY DIFFICULT TO WORK WITH. THE SAMPLE QUALITY IS IMPORTANT TO OBTAIN RESULTS AND INCORRECT SAMPLE HANDLING CAN LEAD TO THE PROBLEM DESCRIBED IN THIS CASE. THE COMPLAINT INDICATES THAT SAMPLE HANDLING COULD BE THE CAUSE OF THIS PROBLEM. CONCERNS ARE EXPRESSED REGARDING IF NEW STAFF IS TRAINED SUFFICIENTLY. SINCE THIS INCIDENT THERE HAS BEEN AN IMPROVEMENT IN THE SUCCESS RATE OF FETAL BLOOD SAMPLES, SINCE THEY HAVE INTRODUCED A POLICY WHERE IF THE 2 FIRST SAMPLES FAIL THEN A NEW OPERATOR MUST RUN THE THIRD SAMPLE.

    Description of Event or Problem · 1

    THREE FETAL SCALP SAMPLES WERE TAKEN AND PUT THROUGH THE ABL800, BUT NO RESULTS WERE OBTAINED. FOR TWO SAMPLES THE ANALYZER REPORTED "NO LEADING AIR SEGMENT" AND FOR ONE SAMPLE THE ANALYZER REPORTED "INSUFFICIENT SAMPLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350482 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS ABL800

    Patients

    Seq Age Sex Outcome Treatment
    1