BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000 PAK

    MDR report key: 3023304 · Received February 28, 2013

    Report

    Report Number
    1217183-2013-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    CEM
    PMA / PMN Number
    K112995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CURRENTLY UNDER EVAL. A FOLLOW-UP REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FROM THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER QUESTIONED TWO POTASSIUM RESULTS REPORTED FROM THEIR GEM PREMIER 4000 CARTRIDGE (PAK): A FIRST SAMPLE WAS ANALYZED THROUGH THE GEM PREMIER 4000, WITH A POTASSIUM RESULT OF 1.9 MMOL/L. THEN THE SAMPLE WAS SENT TO THE LAB, WHERE A POTASSIUM RESULT OF 4.2 MMOL/L WAS OBTAINED. A SECOND SAMPLE WAS ANALYZED THROUGH THE GEM PREMIER 4000 INSTRUMENT, WITH A POTASSIUM RESULT OF 1.4 MMOL/L. THEN THE SAMPLE WAS SENT TO THE LAB, WHERE A POTASSIUM RESULT OF 3.6 MMOL/L WAS OBTAINED. NOTE: PTS WERE NOT TREATED BASED ON THE ABOVE TWO RESULTS FROM THE GEM PREMIER 4000. THE GEM PREMIER 4000 REPORTED MULTIPLE K+ SENSOR ERRORS, BUT DID NOT DISABLE THE CARTRIDGE (PAK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88564 GEM PREMIER 4000 PAK CEM INSTRUMENTATION LABORATORY (IL) CO. 2261 234000K019

    Patients

    Seq Age Sex Outcome Treatment
    1