BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM PREMIER 5000 PAK

    MDR report key: 23165907 · Received September 29, 2025

    Report

    Report Number
    1217183-2025-00045
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 29, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K203790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WERFEN INVESTIGATED THE REPORTED ISSUE AND ACCOMPANYING CARTRIDGE DATA LOGS PROVIDED BY THE CUSTOMER. INVESTIGATION INDICATES THAT THE GEM PAK INTELLIGENT QUALITY MANAGEMENT (IQM), THE QUALITY CONTROL AND ASSESSMENT SYSTEM FOR THE GEM PREMIER 5000, DETECTED POTENTIAL SAMPLE CONTAMINATION AT THE DILUTION LEVEL IN THE AFFECTED SAMPLES. THE SAMPLES IN QUESTION WERE HAVING THEIR ELECTROCHEMICAL (EC) RESULTS SUPPRESSED DUE TO LOW GLUCOSE AND LACTATE WITH HCT < 10%. THIS IS TRIGGERING THE IQM LOW GL SAMPLE CONTAMINATION CHECK, WHICH IS MEANT TO FLAG SAMPLES THAT COULD POTENTIALLY HAVE AN ANALYTICAL ERROR DUE TO SAMPLE POSITIONING. THE SYSTEM WAS APPROPRIATELY FLAGGING AND SUPPRESSING THE EC RESULTS PER IQM. IN ACCORDANCE WITH SYSTEM DESIGN, THE SOFTWARE CORRECTLY BLOCKED THE RESULTS REPORTED BY THE SENSORS ON THE SENSOR CARD. SENSOR PERFORMANCE REMAINED WITHIN ANALYTICAL SPECIFICATIONS, AND THE SYSTEM OPERATED AS EXPECTED PER SOFTWARE REQUIREMENTS. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE GEM PREMIER 5000 (CARTRIDGE SERIAL #: (B)(6) WHICH DEMONSTRATED THAT THE GEM 5000 CARTRIDGE WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE REVEALS THERE IS NO TREND EXCURSION PERTAINING TO THE REPORTED FAILURE MODE. NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 0

    A PATIENT WAS ADMITTED TO THE ICU FOR CONTINUOUS DIALYSIS CVVH. ON (B)(6) 2025, IT WAS OBSERVED THAT THE PATIENT WAS NOT SHOWING ANY LOCOMOTOR ACTIVITY. BLOOD GAS ANALYSIS WAS PERFORMED ON THE GEM PREMIER 5000 (ANALYZER SERIAL NUMBER: (B)(6); GEM PAK (CARTRIDGE) LOT NUMBER: 250528J / SERIAL NUMBER: (B)(6) AND ONLY CO-OXIMETRY RESULTS WERE DISPLAYED; NO RESULTS WERE SHOWN FOR OTHER PARAMETERS. THE DOCTOR PROVIDED THE FOLLOWING TIMELINE: ON - (B)(6) AT 3.13: DOCTOR DISCOVERED THAT THE PATIENT WAS NO LONGER SHOWING ANY LOCOMOTOR ACTIVITY AND SUSPECTED A STROKE. - (B)(6) AT 3:18:29: BLOOD GAS ANALYSIS WAS PERFORMED. ARTERIAL BLOOD GAS SAMPLE SHOWED CO-OX RESULTS ONLY. - (B)(6) AT 3:35:07: A NEW CENTRAL VENOUS SAMPLE WAS TAKEN AND AGAIN SHOWED ONLY CO-OX RESULTS. - (B)(6) AT 3.35:23: A SAMPLE WAS MEASURED ON A SECOND GEM PREMIER 5000 ANALYZER IN THE ICU (SN (B)(6) WHICH ALSO SHOWED ONLY CO-OX RESULTS. PATIENT WAS SUBSEQUENTLY TAKEN FOR CT; THE ANGIOGRAPHY SHOWED NO SIGNS OF A STROKE. - (B)(6) AT 04:40:56: ANOTHER BLOOD GAS ANALYSIS WAS PERFORMED AND AGAIN SHOWED ONLY CO-OX RESULTS. PATIENT'S RESPIRATORY FUNCTIONS AND PRESSURE WORSENED. REANIMATION WAS NOT REQUIRED; THE PATIENT WAS STABILIZED AND INTUBATED. BLOOD GLUCOSE WAS MEASURED WITH A BLOOD GLUCOSE METER WHICH SHOWED A GLUCOSE RESULT OF 10. PATIENT WAS SUBSEQUENTLY TREATED WITH GLUCOSE. - (B)(6) AT 05:30:13: RESULT ON THE SECOND GEM PREMIER 5000 (SN (B)(6) SHOWED A GLUCOSE RESULT < 4 MG/DL. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED BUT WAS UNRESPONSIVE AS OF 09/09/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772173 GEM PREMIER 5000 PAK ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL INSTRUMENTATION LABORATORY CO. 250528J

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown