BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CONTROL LEVEL 3

    MDR report key: 703813 · Received April 24, 2006

    Report

    Report Number
    2245578-2006-00004
    Event Type
    Other
    Date Received
    April 24, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 24, 2006
    Manufacturer
    BIONOSTICS, INC.
    Product Code
    CGA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CONTROL LEVEL 3 CONTROL SOLUTION CGA BIONOSTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other