BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 3802019 · Received February 12, 2014

    Report

    Report Number
    3002807968-2014-00004
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 9, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE INVESTIGATION IS NOT YET COMPLETED. DATA LOGS FORM THE INSTRUMENT HAVE BEEN RECEIVED AND INVESTIGATED, BU THE INVESTIGATION DID NOT REVEAL ANYTHING ABNORMAL. THE CUSTOMER HAS BEEN REQUESTED TO SEND A LIST SHOWING THE LEVEL OF THE DEVIATION FOR THE HIGH NA+ AND CA++ RESULTS. ALSO INFORMATION ABOUT WHETHER THIS PROBLEM HAS BEEN OBSERVED PREVIOUSLY OR IF THIS COULD BE A SINGLE EVENT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE HEALTH CARE PERSONNEL OBSERVED THAT THE ABL 827 ANALYZER HAD BEEN GIVING HIGHER RESULTS THAN USUAL FOR NA++ AND CA++ IN THE PERIOD BETWEEN 07:00 H AND 13:00 H. THE CENTRAL LAB WAS CONTACTED AND THEY REPLACED THE REFERENCE MEMBRANE. AFTER THAT, THE ABL MEASURED CORRECTLY. THE HEALTH CARE PERSONNEL CHECKED ALL 50 TEST RESULTS FORM THE RELEVANT PERIOD AND AFTER CONSULTATION WITH THE RESPONSIBLE DOCTORS, 10 RESULTS WERE DISCARDED. THE HOSPITAL HAD TO RE-RUN SOME OF THE SAMPLES, BUT NO PATIENTS WERE AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92887 ABL800 FLEX ABL827 CHL RADIOMETER MEDICAL APS ABL827

    Patients

    Seq Age Sex Outcome Treatment
    1