BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 5000

    MDR report key: 23076973 · Received September 17, 2025

    Report

    Report Number
    1217183-2025-00043
    Event Type
    Death
    Date Received
    September 17, 2025
    Date of Event
    January 25, 2024
    Report Date
    September 23, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    UDI-DI
    08426950870227
    PMA / PMN Number
    K203790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETERMINED THAT THE CUSTOMER USED DEVICE WITH THE NETWORK TIME PROTOCOL (NTP) DISABLED. IF THE NTP IS DISABLED, THEN IT IS POSSIBLE FOR THE DEVICE'S INTERNAL TIME TO BECOME ASYNCHRONOUS WITH STANDARDIZED EXTERNAL TIME SYSTEMS. THERE WERE NO IDENTIFIED DEVICE MALFUNCTIONS; NOR REPORTS FROM THE CUSTOMER OF ERRONEOUS RESULTS AT THE TIME OF USE. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    ON AUGUST 28, 2025, THE MANUFACTURER RECEIVED A CUSTOMER COMPLAINT REPORTING TIME DISCREPANCY IN BLOOD GAS ANALYSIS PERFORMED ON THE GEM PREMIER 5000. ON (B)(6) 2024, THERE WAS A DISCREPANCY OF APPROXIMATELY 20 MINUTES BETWEEN THE ACTUAL TIME AND THE TIME DISPLAYED ON THE GEM PREMIER 5000. THERE WAS NO REPORT OF ANY MALFUNCTION WITH THE BLOOD GAS ANALYZER AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598505 GEM PREMIER 5000 GEM PREMIER 5000 CHL INSTRUMENTATION LABORATORY CO. 08426950870227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death