BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 19989707 · Received August 15, 2024

    Report

    Report Number
    3002807968-2024-00047
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 30, 2024
    Report Date
    January 21, 2025
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    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

    IT IS BELIEVED THAT THE ISSUE WAS CAUSED BY A PROBLEM IN THE REFERENCE MEASURING CHAMBER, E.G. DEPOSITION OF A BLOOD CLOT OR PRESENCE OF AN AIR BUBBLE IN FRONT OF THE REFERENCE MEMBRANE.

    Additional Manufacturer Narrative · 0

    INITIAL DATE RECEIVED BY MANUFACTURER (AWARENESS DATE) IS 08AUG2024 AND NOT 07AUG2024 AS STATED IN INITIAL REPORT.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE ABL800 FLEX BLOOD GAS ANALYZER (SERIAL NUMBER: (B)(6) OCCURRED SOME ELECTROLYTES ABNORMAL RESULTS WITHOUT ANY ERROR ON THE SAMPLE. A DOCTOR NOTICED ITS RESULT WAS ABNORMAL THEREFORE IT WASN'T AFFECTING ANY HEALTH HAZARD TO THE PATIENT. CUSTOMER INFORMED OF FOLLOWING MEASUREMENTS: SAMPLE ID: (B)(6), (B)(6) 2024 09:07, NA 170 MQ/L (DISCREPANT VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:07, K 6.4 MQ/L (DISCREPANT VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:07, CA 6.27 MQ/DL (DISCREPANT VALUE). . SAMPLE ID: (B)(6) (B)(6) 2024 -30 09:09, NA 140 MQ/L (COMPARISON VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:09, K 5.3 MQ/L (COMPARISON VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:09, CA 4.32 MQ/DL (COMPARISON VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:12, NA 140 MQ/L (COMPARISON VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:12, K 5.3 MQ/L (COMPARISON VALUE). SAMPLE ID: (B)(6), (B)(6) 2024 09:12, CA 4.27 MQ/DL (COMPARISON VALUE). THE CUSTOMER HAS EXPERIENCED HIGH VALUES OF NA, K AND CA ON THE ABL800 FLEX BLOOD GAS ANALYZER (SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683923 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown