BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS ANALYZER

    MDR report key: 24856082 · Received April 13, 2026

    Report

    Report Number
    3002807968-2026-00045
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930923
    PMA / PMN Number
    K160153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(4) A SAMPLE WAS MEASURED ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) AND THE FOLLOWING HEMOGLOBIN (CTHB) RESULTS WERE OBTAINED: 1) (B)(6) 2026, 19:10: 60G/L 2) (B)(6) 2026, 18:39: 105G/L (COMPARISON RESULT FROM THE LAB) ANOTHER SAMPLE WAS ALSO MEASURED ON(B)(6) 2026: 3) (B)(6) 2026, 14:42: 31G/L 4) (B)(6) 2026, 15:06: 138G/L (COMPARISON RESULT FROM ANOTHER ABL90 FLEX PLUS ANALYZER) 5) (B)(6) 2026, 15:13: 137G/L (COMPARISON RESULT) BASED ON THESE, THE CUSTOMER HAD REPORTED THE 60G/L AND 31G/L CTHB MEASUREMENTS FROM THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) AS FALSE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629085 ABL90 FLEX PLUS ANALYZER ABL90 FLEX PLUS ANALYZER CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female