BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLE

    MDR report key: 4097944 · Received September 5, 2014

    Report

    Report Number
    3002807968-2014-00040
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 5, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS INSPECTED BY A TECHNICIAN AND HE CONFIRMED THAT THE ANALYZER WORKED CORRECTLY. DATA LOGS FROM THE ANALYZER HAVE BEEN INVESTIGATED. THE INVESTIGATION INDICATED THAT THE EVENT WAS CAUSED BY A USER ERROR. ACCORDING TO THE DATA LOGS THE ANALYZER WAS IN STATUS 'READY' BEFORE THE USER TRIED TO ASPIRATE A C65UL SAMPLE AT 10:02 AND AGAIN AT 10:04. BOTH TIMES THE ANALYZER GAVE ERROR MESSAGE ' (1271) FAILED TO ASPIRATE SAMPLE' MEANING 'ASPIRATION FAILED SAMPLE NOT DETECTED' ACCORDING TO THE SERVICE MANUAL. THE ONLY TROUBLE SHOOTING DONE BY THE USER WAS TO REMOVE THE SAMPLE INSERT THE SAME SAMPLE AGAIN. THE NEXT SAMPLE WAS RUN AT 13:23 WITHOUT ANY PROBLEMS. THUS, THE COURSE OF EVENTS REPORTED BY THE USER COULD NOT BE CONFIRMED BY THE DATA LOGS.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE ANALYZER STARTED TO CALIBRATE AND FOLLOWING THIS WENT INTO CLEANING MODE WHEN ATTEMPTING TO TEST A FETAL BLOOD SAMPLE. NO PATIENTS WERE AFFECTED BY THIS EVENT AS THE SAMPLES WERE SENT TO THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546372 ABL90 FLE BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL90 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1