BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM PREMIER 4000

    MDR report key: 9935381 · Received April 8, 2020

    Report

    Report Number
    1217183-2020-00001
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    February 8, 2020
    Report Date
    April 7, 2020
    Manufacturer
    INSTRUMENTATION LABORATORY COMPANY
    Product Code
    CHL
    UDI-DI
    08426950452591
    PMA / PMN Number
    K133407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY CONDUCTED AN INVESTIGATION THAT INCLUDED A REVIEW OF DATA FILES FROM THE CUSTOMER'S GEM PREMIER 4000 BLOOD GAS ANALYZER. INVESTIGATION OF SAMPLE DATA DID NOT IDENTIFY ANY FAILURES WITH THE PH SENSOR; HOWEVER, THE SENSOR FILE SHOWED A PH RECOVERY OF 7.17, NOT 7.11 AS INDICATED BY THE CUSTOMER. PER THE CLINICAL ASSESSMENT DONE BY INSTRUMENTATION LABORATORY FOR A PH < 7.2, THE PHYSICIAN'S DECISION TO PROCEED WITH AN URGENT CAESARIAN SECTION IS CONSISTENT WITH CURRENT RECOMMENDATIONS. THE INVESTIGATION CONFIRMED THAT THERE WAS NO PRODUCT MALFUNCTION AND THEREFORE NO REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A COMPLAINT INDICATING QUESTIONABLE FETAL SCALP PH RESULTS AFTER A PH RESULT OF 7.11 WAS DISPLAYED ON A GEM PREMIER 4000 SYSTEM. HOWEVER, THE RESULT COULD NOT BE RETRIEVED IN THE INSTRUMENT AFTER AN ERROR MESSAGE WAS DISPLAYED ("AIR DETECTED WITHIN SAMPLE. DISPLAYED RESULTS QUESTIONABLE"). BASED UPON THE DISPLAYED RESULT, THE PHYSICIAN WAS NOTIFIED, AND THE DECISION WAS MADE TO PROCEED WITH AN URGENT CAESARIAN SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401623 GEM PREMIER 4000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY COMPANY 2261 08426950452591

    Patients

    Seq Age Sex Outcome Treatment
    1 Other