BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 4000

    MDR report key: 1476968 · Received September 10, 2009

    Report

    Report Number
    1217183-2009-00001
    Event Type
    Death
    Date Received
    September 10, 2009
    Report Date
    September 10, 2009
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K061974
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DEATH IS NOT BEING ATTRIBUTED TO THE GEM PREMIER 4000, AND THERE IS NO INDICATION THAT THE INSTRUMENT MALFUNCTIONED OR REPORTED INCORRECT RESULTS. THE CAUSE OF THE PT DEMISE IS UNK, BUT PER THE CUSTOMER, THERE WERE MULTIPLE COMPLICATIONS DURING SURGERY INCLUDING PULMONARY EMBOLISM. THE EVENT IS BEING PUT ON RECORD WITH THE FDA DUE TO THE PT'S OUTCOME ONLY. NO REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR GEM PREMIER 4000 REPORTED SEVERAL GLUCOSE RESULTS OF "< 4 MG/DL" (FLAGGED AS BELOW INSTRUMENT'S REPORTABLE RANGE). THE PT IN QUESTION WAS IN FOR VALVE REPAIR SURGERY AND BECAME CONFUSED, AND UNABLE TO RESPOND TO CERTAIN QUESTIONS PRIOR TO THE PROCEDURE. THE CUSTOMER HAD NEVER SEEN GLUCOSE VALUES AS LOW, BUT IT COMPLAINED THE PT'S MENTAL CONDITION (E.G. UNABLE TO ANSWER QUESTIONS). NOTE: SAMPLES FROM THIS PT WERE ASSAYED ON 3 DIFFERENT GEM PREMIER 4000 ANALYZERS, AND ALL GAVE THE SAME RESULTS. THE PT WAS GIVEN GLUCOSE, WHICH BROUGHT THE GLUCOSE VALUE TO AROUND 200 MG/DL. ULTIMATELY, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM PREMIER 4000 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORY CO. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death