BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2140602 · Received June 16, 2011

    Report

    Report Number
    1217183-2011-00014
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    MZV
    PMA / PMN Number
    K093623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PATIENT BLOOD ANALYSIS, LEADING TO ERRONEOUS RESULTS WITH POTENTIALLY SEVERE IMPACT TO PATIENT 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 INACCURATE RESULTS FROM THE POTASSIUM PARAMETER ON THEIR GEM PREMIER 4000. K+ RESULTS FROM THE GEM PREMIER 4000 WERE TOO LOW WHEN COMPARED TO A REFERENCE ANALYZER. BIASES EXCEED THE INSTRUMENT'S TOTAL ALLOWABLE ERROR CLAIM OF +/- 0.5 MMOL/L.

    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