BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX ANALYZER

    MDR report key: 18967543 · Received March 25, 2024

    Report

    Report Number
    3002807968-2024-00017
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 13, 2024
    Report Date
    June 7, 2024
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURE IS ESTIMATED BASED ON DATE OF EVENT.

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATIONS OF THE PROVIDED DATA SUGGESTS THAT THE DEVIATED MEASUREMENTS WAS DUE TO A BLOOD CLOT DEPOSITED IN FRONT OF THE TIP OF THE REFERENCE ELECTRODE. HENCE THE ROOT CAUSE IS CLOT.

    Additional Manufacturer Narrative · 0

    G3, DATE RECEIVED BY MANUFACTURE IS UPDATED TO THE DAY WHERE RADIOMETER RECEIVED THE AWARENESS DATE OF 2024-03-15.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, SAMPLES WERE MEASURED ON THE ABL800 FLEX ANALYZER (SERIAL NUMBER: (B)(6) AND THE FOLLOWING SODIUM (NA) MEASUREMENTS WERE OBTAINED. 1) MEASURED ON 12:44-240313: 135 MMOL/L (COMPARISON) 2) MEASURED ON 18:08-240313: 168 MMOL/L 3) MEASURED ON 18:38-240313: 170 MMOL/L 4) MEASURED ON 19:02-240313: 172 MMOL/L 5) MEASURED ON 01:56-240314: 133 MMOL/L (COMPARISON) BASED ON THESE, THE CUSTOMER HAD REPORTED THE 168 MMOL/L, 170 MMOL/L AND 172 MMOL/L NA AS FALSE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15050 ABL800 FLEX ANALYZER ABL800 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male