BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSOM HCG COMBO TEST

    MDR report key: 16214011 · Received January 20, 2023

    Report

    Report Number
    16214011
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 29, 2022
    Report Date
    December 28, 2022
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE URINE WAS NOT ABLE TO PASS THROUGH CASSETTE TO RESULT ON PREGNANCY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363540 OSOM HCG COMBO TEST VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI SEKISUI DIAGNOSTICS, LLC 221418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown