BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2140412 · Received June 17, 2011

    Report

    Report Number
    1217183-2011-00017
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 17, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    MZV
    PMA / PMN Number
    K093623
    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 RARE OCCURRENCES OF FALSELY LOWERED K+ RESULTS (POTENTIAL NEGATIVE BIAS OF 0.6 TO 1.2 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)(6.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE K+ RESULTS ON THE GEM PREMIER 4000 WERE TOO LOW WHEN COMPARED TO ANOTHER GEM PREMIER 4000 INSTRUMENT AND TO THEIR LABORATORY REFERENCE INSTRUMENT. BIASES EXCEED THE INSTRUMENT'S TOTAL ALLOWABLE ERROR CLAIM OF (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1