BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 5000

    MDR report key: 17239800 · Received June 30, 2023

    Report

    Report Number
    1217183-2023-00003
    Event Type
    Death
    Date Received
    June 30, 2023
    Date of Event
    February 27, 2023
    Report Date
    July 28, 2023
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    UDI-DI
    08426950870227
    PMA / PMN Number
    K203790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 27, 2023, A WERFEN REPRESENTATIVE CONTACTED OUR IT DEPARTMENT ABOUT PROBLEMS ACCESSING THE GEMWEB PLUS (GWP) WITH THE GEM PREMIER 5000 ANALYZERS, WHICH WERE REPORTING DISCONNECTIONS. CUSTOMER INVESTIGATIONS NOTED THAT THERE WERE DISCONNECT/RECONNECTIONS, AN UNSTABLE STATE, WITH THEIR LIS. THE HOSPITAL'S VARIOUS DEPARTMENTS WENT INTO STAND-ALONE MODE. IL (WERFEN) INVESTIGATION FOUND THAT A LOGICAL DISK WAS ALMOST FULL, WHICH COULD HAVE HAD AN IMPACT ON THE OPERATION OF GEMWEB PLUS. WERFEN IT DEPARTMENT PROVIDED A PROCEDURE FOR DELETING TEMPORARY DISK TRACE FILES. ONCE THE PROCEDURE HAD BEEN APPLIED BY THE HOSPITAL'S DATA CENTER MANAGER AND THE GEMWEB PLUS MACHINE HAD BEEN RESTARTED, CONNECTIONS WITH THE GEM PREMIER WERE RESTORED AND THE GEMWEB PLUS INTERFACE WAS ONCE AGAIN ACCESSIBLE. TO RESOLVE THE ISSUE GEMWEB PLUS DEBUG MODE NEEDED TO BE SWITCHED FROM EXPERT MODE (WHICH CONSUMES A LOT OF DISK SPACE AND IS USED FOR INVESTIGATIONS) TO STANDARD MODE. THIS CUSTOMER HAS SWITCHED TO STANDARD MODE. THIS CUSTOMER ISSUE WAS RESOLVED WITH THESE ACTIONS. THE PATIENT WAS RECEIVING APPROPRIATE MEDICAL TREATMENT THROUGHOUT THE SOFTWARE DOWNTIME AND THE PATIENT UNFORTUNATELY DIED THE NEXT DAY, OVER 24 HOURS FROM ADMISSION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY ONGOING; A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT CONNECTION WITH LIS WAS IN AN UNSTABLE STATE (CONNECTIONS/DISCONNECTIONS). THE GEM PREMIER 5000 CONNECTIONS AND TRANSFERS TO GWP WERE AFFECTED. DURING THE VARIOUS DISCONNECTIONS, A 10-YEAR-OLD PATIENT WAS IN ABSOLUTE EMERGENCY. THIS PATIENT NEEDED TO HAVE A GASOMETRY PERFORMED TO ADAPT HIS TREATMENT. ALL INSTRUMENTS IN THE EMERGENCY DEPARTMENT (OUTSOURCED BIOLOGY) DID NOT WORK AND WERE UNABLE TO CARRY OUT THE REQUESTED EXAMINATION, THE PATIENT WAS ADMITTED ON (B)(6) 2023 AT 3:19. CUSTOMER REPORTED THAT BLOOD GAS RESULTS WERE PROVIDED AT 5:02PM. THE MANUFACTURER WAS INFORMED ON JUNE 7TH 2023 THAT THE PATIENT DIED ON (B)(6) 2023, CAUSE OF DEATH WAS NOT SHARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20101 GEM PREMIER 5000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY CO. 2262 08426950870227

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown Death