BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2243613 · Received July 27, 2011

    Report

    Report Number
    1217183-2011-00089
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 26, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CEM
    PMA / PMN Number
    K083623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A KNOWN ISSUE ON THE GEM PREMIER 4000 SYSTEM OF FALSELY LOWERED K+ RESULTS (POTENTIAL NEGATIVE BIAS OF 0.6 TO 2.0 MMOL/L) THAT CAN OCCUR DURING CARTRIDGE LIFE ON PT BLOOD ANALYSIS, LEADING TO ERRONEOUS RESULTS WITH POTENTIALLY SEVERE IMPACT TO PT TREATMENT. RECALL: A RECALL HAS BEEN INITIATED TO NOTIFY THE FIELD REGARDING THE ISSUE WITH K+ REPORTING ON THE GEM PREMIER 4000. THIS RECALL ACTION WAS SUBMITTED AND WILL BE TRACKED THROUGH (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE POTASSIUM VALUES ON THE GEM PREMIER 4000 WERE TO LOW AGAINST THEIR REFERENCE LAB INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1