BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMSTAT

    MDR report key: 10894314 · Received November 23, 2020

    Report

    Report Number
    MW5098041
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    November 14, 2020
    Report Date
    November 20, 2020
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GLK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    CHEMSTAT DONE IN ED TO CHECK HEMOGLOBIN/HEMATOCRIT LEVELS DUE TO PATIENT PRESENTING WITH ACTIVE GI BLEED. PER CHEMSTAT, H&H 5/15 AND EDMD PLACED ORDERS TO TRANSFUSE 2 UNITS PRBCS BASED ON RESULTS. LAB CBC RESULTED WITH H&H 12.6/37 PRIOR TO INITIATION OF TRANSFUSION, SO ORDERS DISCONTINUED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347556 CHEMSTAT CONTROL, HEMATOCRIT GLK INSTRUMENTATION LABORATORY CO. 20020128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention