BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 4000

    MDR report key: 6347313 · Received February 21, 2017

    Report

    Report Number
    1217183-2017-00001
    Event Type
    Death
    Date Received
    February 21, 2017
    Date of Event
    December 30, 2016
    Report Date
    February 21, 2017
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    UDI-DI
    08426950452591
    PMA / PMN Number
    K133407
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY (IL) CONDUCTED AN INVESTIGATION THAT INCLUDED A REVIEW OF DATA FILES FROM THE CUSTOMER'S GEM PREMIER 4000. THE DATA REVIEW SHOWED THAT THE DEVICE WAS OPERATING WITHIN THE SPECIFICATIONS. THERE WAS NO SYSTEM OR SENSOR MALFUNCTION DURING ANALYSIS OF THE PATIENT'S SAMPLES. THE CUSTOMER STATED THAT THERE WAS NO CORRELATION OF THIS PATIENT'S DEATH TO GEM PREMIER 4000 INSTRUMENT PERFORMANCE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REQUESTED INSTRUMENTATION LABORATORY (IL) TO REVIEW TWO GLUCOSE RECOVERIES FROM A GEM PREMIER 4000 INSTRUMENT. BOTH SAMPLES WERE FROM THE SAME PATIENT. THE SAMPLES WERE ANALYZED ON (B)(6) 2016. THE FIRST SAMPLE ANALYZED AT 12:56 PRODUCED AN INCALCULABLE GLUCOSE RESULT. THE SECOND SAMPLE ANALYZED AT 13:37 PRODUCED A GLUCOSE RESULT OF >41.6 MMOL/L. IL WAS INFORMED THAT THE PATIENT DIED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127984 GEM PREMIER 4000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY CO. 2261 08426950452591

    Patients

    Seq Age Sex Outcome Treatment
    1 Death