BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 5000

    MDR report key: 7784056 · Received August 15, 2018

    Report

    Report Number
    1217183-2018-00005
    Event Type
    Death
    Date Received
    August 15, 2018
    Date of Event
    June 29, 2018
    Report Date
    August 15, 2018
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    UDI-DI
    08426950870227
    PMA / PMN Number
    K173403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY (IL) CONDUCTED AN INVESTIGATION THAT INCLUDED A REVIEW OF THE DATA FILES FROM THE CUSTOMER'S GEM PREMIER 5000 INSTRUMENTS. THE DATA REVIEW SHOWED THAT THE DEVICES WERE OPERATING WITHIN SPECIFICATIONS. THERE WAS NO SYSTEM OR SENSOR MALFUNCTION DURING ANALYSIS OF THE PATIENT'S SAMPLES. FOR THE SAMPLES IN QUESTION, ALL RECOVERIES WERE REPORTED AS INCALCULABLE, EXCEPT CO-OX AND ITS FRACTIONS. IT SHOULD BE NOTED THAT THE RESULTS WERE FLAGGED, INCLUDING GLUCOSE, AS "INCALCULABLE", WHICH THE OPERATOR'S MANUAL INDICATES AS "REQUIRED MEASUREMENT CRITERIA WERE NOT MET DURING SAMPLE ANALYSIS". THE INVESTIGATION CONCLUDED THAT THE INSTRUMENTS WERE OPERATING WITHIN SPECIFICATION AND, THEREFORE, NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED INDICATING A DEATH IN A PATIENT WHO DEVELOPED HYPOGLYCEMIA FOLLOWING A MEDICATION ERROR WHERE INSULIN WAS ADMINISTERED INSTEAD OF HEPARIN BECAUSE OF AN INCORRECTLY LABELED SYRINGE PUMP. THE COMPLAINT STATES THAT ARTERIAL SAMPLES WERE TESTED ON MULTIPLE GEM PREMIER 5000 ANALYZERS ON (B)(6) 2018. THE ELECTROCHEMICAL RESULTS WERE NOT REPORTED AND THERE WERE NO ERROR MESSAGES. AS A RESULT, THE COMPLAINT ALLEGES A DELAY IN OBTAINING GLUCOSE RESULTS, WHICH IF AVAILABLE SOONER COULD HAVE ASSISTED THE CLINICAL TEAM WITH THE PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628875 GEM PREMIER 5000 CLINICAL CHEMISTRY INSRUMENT CHL INSTRUMENTATION LABORATORY 2262 08426950870227

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death