BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 12777887 · Received November 9, 2021

    Report

    Report Number
    3002807968-2021-00059
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 4, 2021
    Report Date
    December 9, 2021
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938011
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA LOGS FROM THE AFFECTED DEVICES WERE INVESTIGATED. UNFORTUNATELY, THE ROOT CAUSE COULD NOT BE ESTABLISHED, BUT THE INVESTIGATION FINDINGS INDICATED THAT THE PREANALYTICAL SAMPLE HANDLING COULD BE THE CAUSE.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT ON (B)(6) 2021, WHEN THE CUSTOMER MEASURED A BLOOD SAMPLE ON THE ABL800 FLEX ANALYZER, THE RESULT OF K+ WAS 8.1 MEQ/L, WHICH IS HIGHER THAN EXPECTED VALUE FOR ABOUT 4~5 MEQ/L. THEREFORE, THEY DOUBTED THE RESULT FROM THE ABL800 FLEX ANALYZER, AND THEN THEY CHECKED ANOTHER RESULT FROM THE ANALYZER ON LAB. THE RESULT OF K+ FROM LAB'S ANALYZER WAS EXPECTED VALUE. NO ADVERSE EVENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675721 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800 05700693938011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown