BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 1970514 · Received January 19, 2011

    Report

    Report Number
    1217183-2011-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    October 21, 2010
    Report Date
    January 18, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K093623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE DESCRIPTION: AN INTERNAL IL INVESTIGATION OF THE CUSTOMER CARTRIDGE DATA IDENTIFIED THAT ONE OF THE SAMPLES IN QUESTION EXPERIENCED AN AMPEROMETRIC SPIKE, CAUSING AN OUT OF SPEC GLUCOSE AND LACTATE RESULT. THE OTHER SAMPLE RESULTS WERE WITHIN SPEC. RECALL (FIELD NOTICE) TO BE INITIATED: A RECALL WILL BE INITIATED TO NOTIFY THE FIELD OF THE RARE ISSUE AND TO PROVIDE WORK AROUND INSTRUCTIONS. THE RECALL ACTION WILL BE SUBMITTED AND TRACKED THROUGH THE LOCAL (B)(4) FDA DISTRICT OFFICE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED THAT DURING A CORRELATION STUDY BETWEEN TWO GE PREMIER 4000 INSTRUMENTS, PT SAMPLE PAIRS REPORTED AN UNACCEPTABLE DIFFERENCE IN RESULTS FOR GLUCOSE AND LACTATE. NOTED: THERE WAS NO CHANGE TO PT TREATMENT OR ADVERSE EVENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM PREMIER 4000 BLOOD GAS AND ELECTROLYTE ANALYZER CHL INSTRUMENTATION LABORATORY CO. 2261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1