BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDLAB BLOOD GAS ANALYZER

    MDR report key: 496434 · Received November 19, 2003

    Report

    Report Number
    1217157-2003-00002
    Event Type
    Injury
    Date Received
    November 19, 2003
    Date of Event
    October 19, 2003
    Report Date
    November 4, 2003
    Manufacturer
    BAYER HEALTHCARE LLC SUBSIDUARY OF BAYER CORP.
    Product Code
    CHL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAYER HEALTHCARE RECEIVED CUSTOMER COMPLAINT THAT THE RAPIDLAB 860 BLOOD GAS ANALYZER GAVE ELEVATED GLUCOSE RESULTS ON SAMPLES FROM FOUR PTS. ACTING ON THE RESULTS THE MEDICAL STAFF INCREASED THE INSULIN LEVELS BEING GIVEN. EACH TIME CHECKING THE GLUCOSE ON THE RL 860 AND FINDING IT ELEVATED. SAMPLES WERE CHECKED WITH GLUCOMETER (RESULTS SHOWED VERY LOW GLUCOSE) AND TREATMENT WAS REVERSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB BLOOD GAS ANALYZER BLOOD GAS ANALYZER CHL BAYER HEALTHCARE LLC SUBSIDUARY OF BAYER CORP. 860 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening