BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 4000

    MDR report key: 5973676 · Received September 23, 2016

    Report

    Report Number
    1217183-2016-00002
    Event Type
    Death
    Date Received
    September 23, 2016
    Date of Event
    March 29, 2016
    Report Date
    July 18, 2016
    Manufacturer
    INSTRUMENTATION LABORATORY - BEDFORD
    Product Code
    CHL
    PMA / PMN Number
    K133407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY (IL) CONDUCTED AN INVESTIGATION THAT INCLUDED A REVIEW OF ELECTRONIC DATA FILES FROM THE CUSTOMER'S GEM PREMIER 4000. THE DATA SHOWED NO INDICATION OF INSTRUMENT AND/OR GLUCOSE SENSOR MALFUNCTION DURING SAMPLE ANALYSIS, SUPPORTING A VALID LOW GLUCOSE RESULT. THEREFORE, THE GEM PREMIER 4000 PERFORMED AS INTENDED AND NO REMEDIAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REQUESTED INSTRUMENTATION LABORATORY (IL) TO VERIFY A GLUCOSE TEST RESULT FROM A GEM PREMIER 4000 INSTRUMENT. THE GLUCOSE RESULT ON (B)(6) 2016 WAS 1.4 MMOL/L (25.2 MG/DL). THE PATIENT INVOLVED WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE THERAPY UNIT (ITU), AND DIED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625493 GEM PREMIER 4000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY - BEDFORD 2261

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death