BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER CHEMSTAT PAK

    MDR report key: 21589202 · Received March 12, 2025

    Report

    Report Number
    1217183-2025-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    July 26, 2023
    Report Date
    March 12, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JFY
    UDI-DI
    08426951070800
    PMA / PMN Number
    K223090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THE REPORTED COMPLAINT, INSTRUMENTATION LABORATORY CO. CONDUCTED A COMPREHENSIVE INVESTIGATION, INCLUDING A REVIEW OF THE DATA FROM THE GEM PREMIER CHEMSTAT PAK (CARTRIDGE) IN QUESTION. THE REVIEW CONFIRMED THAT THE CREATININE SENSOR WAS OPERATING WITHIN SPECIFICATIONS, AND THE ROOT CAUSE OF THE BIAS SEEN BETWEEN THE GEM PREMIER CHEMSTAT AND THE LABORATORY METHODS (JAFFE AND ENZYMATIC CREATININE ASSAYS) COULD NOT BE CONCLUSIVELY DETERMINED. AS A RESULT, THE COMPLAINT WAS CLOSED, AND NO REMEDIAL ACTION WAS DEEMED NECESSARY. IMPORTANT NOTE: INSTRUMENTATION LABORATORY CO. RECENTLY CONDUCTED A SELF-ASSESSMENT OF ITS QUALITY MANAGEMENT SYSTEM AS PART OF ITS ONGOING COMPLIANCE AND QUALITY PROGRAM DUE DILIGENCE. ONE ASPECT OF THIS ASSESSMENT WAS TO PERFORM A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS RECEIVED OVER THE PAST TWO YEARS, TO ASSESS IF ANY COMPLAINTS SHOULD HAVE BEEN REPORTED TO FDA FOLLOWING THE FDA GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS". AS PART OF THIS ASSESSMENT, WE IDENTIFIED A SMALL NUMBER OF COMPLAINTS THAT REQUIRE RETROSPECTIVE REPORTING. PLEASE BE ASSURED THAT INSTRUMENTATION LABORATORY TAKES ITS REGULATORY RESPONSIBILITIES TO THE FDA AND ITS CUSTOMERS SERIOUSLY AND STRIVES TO PRODUCE ONLY THE HIGHEST QUALITY DEVICES. THE NUMBER OF LATE REPORTED COMPLAINTS IS LESS THAN 0.005% OF THE ANNUAL COMPLAINT VOLUME RECEIVED AND A CAPA HAS BEEN INITIATED TO MITIGATE FUTURE OCCURRENCES. FURTHERMORE, THE COMPANY HAS AND WILL CONTINUE TO DEDICATE THE NECESSARY FINANCIAL AND PERSONNEL RESOURCES (AND MANAGEMENT OVERSIGHT) TO COMPLETE THESE ACTION PLANS IN A TIMELY MANNER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE IMPLAUSIBLY HIGH FOR FIVE PATIENT SAMPLES COMPARED TO RESULTS ON A DIFFERENT GEM PREMIER CHEMSTAT SYSTEM, AS WELL AS TO THEIR LABORATORY METHODS (JAFFE AND ENZYMATIC CREATININE ASSAYS). NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917949 GEM PREMIER CHEMSTAT PAK ENZYMATIC METHOD, CREATININE JFY INSTRUMENTATION LABORATORY CO. 230516A 08426951070800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown