BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOSE TOLERANCE BEVERAGE

    MDR report key: 20733529 · Received November 20, 2024

    Report

    Report Number
    20733529
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    February 10, 2024
    Report Date
    June 10, 2024
    Manufacturer
    AZER SCIENTIFIC, INC.
    Product Code
    MRV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INCORRECT DOSE OF GLUCOSE DRINK WAS ADMINISTERED DURING THE 1HR OB GLUCOSE TOLERANCE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937936 GLUCOSE TOLERANCE BEVERAGE DRINK, GLUCOSE TOLERANCE MRV AZER SCIENTIFIC, INC. 10-O-050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female