BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS ANALYZER

    MDR report key: 20478911 · Received October 18, 2024

    Report

    Report Number
    3002807968-2024-00068
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 16, 2024
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930923
    PMA / PMN Number
    K160153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATIONS SHOWED THAT THE DESIGN OF THE CAPILLARY TUBE HOLDER IS UNSUITABLE TO BE REOPENED MULTIPLE TIMES. HENCE THE ROOT CAUSE IS PHYSICAL DAMAGE OF THE PACKAGING.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE ABL90 FLEX PLUS BLOOD GAS ANALYZER (SERIAL NUMBER: (B)(6) PRESENTED MEASUREMENT ERROR CODES: 1271 (FAILED TO ASPIRATE SAMPLE), 593 (INSUFFICIENT SAMPLE) AND 331 (NO SAMPLE DETECTED DURING SAMPLE ASPIRATION). THE CUSTOMER SUSPECTS IT COULD BE DUE TO DUST FROM THE CONTAINER OF THE SAFECLINITUBE (ITEM NUMBER: 942-892, LOT NUMBER: R3083).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271207 ABL90 FLEX PLUS ANALYZER ABL90 FLEX PLUS ANALYZER CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown