BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER CHEMSTAT PAK

    MDR report key: 23840513 · Received December 18, 2025

    Report

    Report Number
    1217183-2025-00056
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 18, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JFY
    UDI-DI
    08426951070800
    PMA / PMN Number
    K223090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COPYILDATA FILE FROM THE GEM PREMIER CHEMSTAT INSTRUMENT PROVIDED BY THE CUSTOMER WAS PERFORMED AND DID NOT INDICATE ANY INSTRUMENT ERRORS OR ANOMALIES. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GEM PREMIER CHEMSTAT CARTRIDGE (SERIAL NUMBER (B)(6)) CONFIRMED THAT THE CARTRIDGE MET ALL ESTABLISHED MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS, WITH NO NONCONFORMITIES IDENTIFIED. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY TRENDS OR EXCURSIONS PERTAINING TO THE REPORTED FAILURE MODE. ACCORDINGLY, NO REMEDIAL ACTION IS INDICATED. NOTE: THIS MDR FILING IS PAST THE 30-DAY REPORTING TIMEFRAME DUE TO AN INTERNAL ERROR IN COMPLAINT ASSIGNMENT TO THE APPROPRIATE RISK ASSESSMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED HIGHER THAN EXPECTED CREATININE RESULTS FROM THEIR GEM PREMIER CHEMSTAT, WITH SOME RESULTS DOCUMENTED IN THE PATIENT MEDICAL RECORD. REPEAT TESTING PERFORMED BY THE CUSTOMER ON A LABORATORY CHEMISTRY ANALYZER YIELDED LOWER CREATININE RESULTS. NO IQM (INTELLIGENT QUALITY MANAGEMENT) FLAGS OR OTHER ERRORS WERE REPORTED BY THE GEM PREMIER CHEMSTAT INSTRUMENT. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257652 GEM PREMIER CHEMSTAT PAK ENZYMATIC METHOD, CREATININE JFY INSTRUMENTATION LABORATORY CO. 250818A 08426951070800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown