BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER CHEMSTAT PAK

    MDR report key: 22161314 · Received June 6, 2025

    Report

    Report Number
    1217183-2025-00034
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 9, 2025
    Report Date
    November 7, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JFY
    UDI-DI
    08426951070800
    PMA / PMN Number
    K223090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DATA SUBMITTED BY CUSTOMER WAS REVIEWED. DATA REVIEW SHOWED THAT THE CREATININE SENSOR PERFORMANCE WAS WITHIN SPECIFICATIONS (FOR IQM PROCESSES AND CVPS) FOR GEM PREMIER CHEMSTAT S/N (B)(6), GEM PREMIER CHEMSTAT PAK S/N (B)(6). DATA REVIEW CONCLUDED THE GEM CHEMSTAT PAK CREATININE SENSOR WAS FOUND PERFORMING TO CLAIMS AND WITHIN OUR ON-BOARD INTELLIGENT QUALITY MANAGEMENT (IQM) LIMITS (WITH ACCEPTABLE SLOPES, DRIFTS, CVP RECOVERY, AND SENSOR MV BASELINE STABILITY. FURTHERMORE, NO TRANSIENT FLUIDIC OR ELECTRICAL ISSUE WERE IDENTIFIED DURING SAMPLE MEASUREMENTS. THE REVIEWED GEM PAK DATA DID NOT INDICATE ANY SYSTEMATIC ISSUE IN THE PAK TO ACCOUNT FOR THE QUESTIONED CREATININE RESULTS. THE GEM PREMIER CHEMSTAT S/N (B)(6) INSTRUMENT WAS RETURNED FOR EVALUATION. WERFEN ENGINEERS WERE UNABLE TO IDENTIFY ANY PHYSICAL AND ELECTRICAL DEFECTS. THE DEVICE PASSED ALL TESTING WITH NO ERRORS RECREATED. THE MANUFACTURING RECORDS WERE REVIEWED FOR GEM PREMIER CHEMSTAT PAK S/N (B)(6) WHICH SHOWED ALL MANUFACTURING AND QA SPECIFICATIONS PASSED. WHILE A SPECIFIC ROOT CAUSE OF THE HIGH CREATININE RESULTS COULD NOT BE CONCLUSIVELY DETERMINED, IT IS SUSPECTED THE ERRONEOUSLY HIGH CREATININE RESULTS WAS RELATED TO PATIENT SAMPLES CONTAINING UNKNOWN INTERFERENCE SUBSTANCE. A REVIEW OF THE COMPLAINT DATABASE REVEALS THERE IS NO TREND EXCURSION PERTAINING TO THE REPORTED FAILURE MODE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. AS A RESULT, THE COMPLAINT WAS CLOSED, AND NO REMEDIAL ACTION WAS DEEMED NECESSARY.

    Description of Event or Problem · 0

    FOLLOWING REPORTS OF SPURIOUS CREATININE RESULTS ON THE GEM PREMIER CHEMSTAT (SERIAL NUMBER (B)(6)) AND A FULL INSTRUMENT HEALTH CHECK BY A WERFEN ENGINEER, WERFEN APPLICATION SPECIALISTS ANALYSED 10 X PATIENT BLOOD SAMPLES AGAINST A SECOND CHEMSTAT AND FOUND THAT THE CHEMSTAT IN QUESTION IN THIS CASE (SN (B)(6)) CONSISTENTLY PRODUCED ELEVATED CREATININE RESULTS. THIS WAS A BLOOD SAMPLE COMPARISON, NO PATIENTS HAVE BEEN AFFECTED IN THIS PARTICULAR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619869 GEM PREMIER CHEMSTAT PAK ENZYMATIC METHOD, CREATININE JFY INSTRUMENTATION LABORATORY CO. 250318B 08426951070800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown