BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS ANALYZER

    MDR report key: 22393107 · Received July 3, 2025

    Report

    Report Number
    3002807968-2025-00086
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 12, 2025
    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

    Additional Manufacturer Narrative · 0

    INFORMATION FROM COMPLAINT HANDLER: DATE OF INCIDENT IS DATED 12 MONTHS BACK FROM (B)(6) 2024 TO (B)(6) 2025.

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATION LOOKED INTO THE SUPPLIED DATA LOGS, QUALITY CONTROL LOGS (OVER THE LAST 11 MONTHS), CALIBRATION LOGS (LAST TWO WEEKS) AND SYSTEM MESSAGE, WHICH DO NOT SHOW ANY GENERAL MALFUNCTIONING OF THE ABL90 MEASUREMENT ON NA. NO EVIDENCE OF GENERAL MALFUNCTIONING OF NA RESULTS ACCORDING TO SYSTEM MESSAGE, QUALITY CONTROL AND CALIBRATION LOGS. ROOT CAUSE IS SOMETHING OTHER THAN THE DEVICE OR USAGE. THEREFORE, THIS EVENT DOES NOT MEET THE CRITERIA OF A MDR REPORTABLE EVENT.

    Description of Event or Problem · 0

    RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER HAS EXPRESSED CONCERNS WITH SODIUM (NA) RESULTS GOING BACK 12 MONTHS. AT PRESENT, THIS HAS BEEN IDENTIFIED ACROSS TWO ABL90 FLEX PLUS ANALYZERS, WHERE TWO CT1-CASES ARE RAISED, THIS CURRENT CT1-024299 WITH ANALYZER SERIAL NUMBER (B)(6), AND THE OTHER AS CT1-024298 WITH ANALYZER SERIAL NUMBER (B)(6). DATA FILE LOG PROVIDED BY CUSTOMER CONTAINS THE SAME MEASUREMENTS FOR BOTH CASES. NO REPORTS OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176878 ABL90 FLEX PLUS ANALYZER ABL90 FLEX PLUS ANALYZER CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown