BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 5000 PAK

    MDR report key: 21002085 · Received December 23, 2024

    Report

    Report Number
    1217183-2024-00012
    Event Type
    Death
    Date Received
    December 23, 2024
    Date of Event
    August 9, 2024
    Report Date
    March 13, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K203790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED ON NOVEMBER 1, 2024 AND DETERMINED THE INSTRUMENT WAS OPERATING TO SPECIFICATION. THIS INCIDENT IS BEING REPORTED DUE TO ADDITIONAL INFORMATION RECEIVED ON DECEMBER 4, 2024, INDICATING PATIENT DEATH. FURTHER INFORMATION IS CURRENTLY BEING OBTAINED ON PATIENT OUTCOME. INVESTIGATION OF THE CARTRIDGE DATA SHOWED THAT FOR THE SAMPLES IN QUESTION, IQM2 CORRECTLY DETECTED SAMPLES THAT WERE POTENTIALLY AFFECTED WITH A PRE-ANALYTICAL OR ANALYTICAL ISSUE AND, THEREFORE, SAMPLES RESULTS WERE CORRECTLY BLOCKED. REVIEW OF MANUFACTURING RECORDS FOR THE CARTRIDGE IN QUESTION, GEM PREMIER 5000 PAK SERIAL # (B)(6), SHOWED THAT THE CARTRIDGE PASSED ALL MANUFACTURING AND QA SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE REVEALS THERE IS NO TREND EXCURSION PERTAINING TO THE REPORTED FAILURE MODE. A FOLLOW-UP REPORT WILL BE FILED WHEN MORE INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION PERFORMED HAS INDICATED THAT ALL SENSORS WERE PERFORMING WITHIN THE CLAIMED ANALYTICAL PERFORMANCE REQUIREMENTS. THE GEM PREMIER 5000 SYSTEM DID NOT REPORT ANY INCORRECT RESULTS SINCE IQM2 OPERATED WITHIN SPECIFICATIONS, CORRECTLY SUPPRESSING RESULTS FROM SAMPLES THAT MAY HAVE BEEN COMPROMISED DUE TO SAMPLE DILUTION EVENTS FROM EITHER PRE-ANALYTICAL OR ANALYTICAL FACTORS. SAMPLE RESULTS FROM SENSORS LOCATED IN THE COMMON FLUIDIC PATH WERE SUPPRESSED AS EXPECTED. SAMPLE RESULTS FROM SENSORS LOCATED IN A DIFFERENT FLUIDIC PATH (CO-OXIMETRY) WERE UNAFFECTED BY THIS EVENT AND WERE REPORTED AS EXPECTED. FOLLOWING GEM PAK INSERTION AND WARM-UP, ALL ANALYTES PASSED AUTOMATED PAK VALIDATION (APV) AND ALL OTHER REQUIRED INTERNAL QUALITY CONTROL CHECKS. THE INVESTIGATION CONFIRMED THAT THE SYSTEM WAS PERFORMING WITHIN THE SYSTEM ANALYTICAL CLAIMS AND SOFTWARE REQUIREMENTS THROUGHOUT THE LIFE OF THE CARTRIDGE. DURING SAMPLE ANALYSIS THE SAMPLES IN QUESTIONS WERE IDENTIFIED BY IQM2 AS POTENTIALLY COMPROMISED AND SUPPRESSED THE RESULTS, IN LINE WITH SYSTEM SPECIFICATIONS. THIS EVENT COULD HAVE BEEN CAUSED BY PRE-ANALYTICAL OR ANALYTICAL FACTORS. AS DESIGNED, THE SUPPRESSED RESULTS WERE DISPLAYED TO THE OPERATOR AS "INCALCULABLE." THE MANUFACTURING RECORDS WERE REVIEWED FOR THE GEM PREMIER 5000 (CARTRIDGE SERIAL #: (B)(6)) WHICH DEMONSTRATED THAT THE GEM PREMIER 5000 CARTRIDGE WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE REVEALS THERE IS NO TREND PERTAINING TO THE REPORTED FAILURE MODE. UNABLE TO DETERMINE THE ROOT CAUSE OF INCALCULABLE RESULTS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THIS EVENT HAS BEEN EVALUATED AS REPORTABLE BECAUSE A DEATH WITH AN UNKNOWN CAUSE HAS BEEN REPORTED, HOWEVER IT HAS NOT BEEN CONFIRMED THAT THE DEATH WAS CAUSED OR CONTRIBUTED BY THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 14-MONTH-OLD MALE PATIENT WITH IDIOPATHIC CHRONIC PLEURAL EFFUSION UNDERWENT FOLLOW-UP FOR IDIOPATHIC CHRONIC PERICARDIAL EFFUSION, WITHOUT STRUCTURAL HEART DISEASE OR HEMODYNAMIC REPERCUSSIONS. THE PATIENT WAS ADMITTED FOR SURGERY: PLEUROPERICARDIAL WINDOW BY THORACOSCOPY AND OPERATED ON (B)(6) 2024. FOLLOWING SURGERY, THE PATIENT WAS TRANSFERRED TO THE ICU. A BLOOD GAS ANALYSIS WAS PERFORMED AND SHOWED A BLOOD GLUCOSE LEVEL OF 23 MG/DL. IT WAS REPORTED THAT HYPOGLYCEMIA WAS SEEMINGLY NOT DETECTED DURING SURGERY DUE TO REPEATED ERRORS DURING THE PROCESSING OF THREE ARTERIAL BLOOD GAS SAMPLES IN A TOTAL OF FIVE TESTS. ALL THREE SAMPLES WERE TAKEN FROM AN ARTERIAL CATHETER IN WHICH NO MEDICATION WAS BEING ADMINISTERED THROUGH. IN THE FIVE ANALYSES PERFORMED, THE RESULTS FOR GLUCOSE, LACTATE, PH, PCO2, PO2, IONS AND HEMATOCRIT APPEAR AS INCALCULABLE. ONLY THE COOXIMETRY PARAMETERS SHOWED A RESULT. THERE WERE NO INDICATIONS REGARDING THE POSSIBLE CAUSE. THE INCIDENT WAS REPORTED BY THE CUSTOMER TO DETERMINE THE CAUSE OF THE INCALCULABLE PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85031 GEM PREMIER 5000 PAK ELECTRODE MEASUREMENT, BLOOD GASES CHL INSTRUMENTATION LABORATORY CO. 240530K

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Male Death