BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPREDIA-SUPERFROST SLIDES

    MDR report key: 15592545 · Received October 12, 2022

    Report

    Report Number
    15592545
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 19, 2022
    Manufacturer
    NEW ERIE SCIENTIFIC LLC
    Product Code
    KES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EPREDIA¿ PREMIUM MICROSCOPE SLIDES USED FOR AMNIOTIC FLUID SAMPLE COLLECTED ON SLIDE AND VIEWED BY PROVIDER UNDER MICROSCOPE FOR FERNING TEST. PATIENT WAS VISUALLY GROSSLY RUPTURED, NO FERNS SEEN ON SLIDE. CONCERN WITH SLIDES AND INCORRECT READING. ANOTHER SLIDE PRODUCT WAS USED AND TEST CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582956 EPREDIA-SUPERFROST SLIDES COVERSLIPS, MICROSCOPE SLIDE KES NEW ERIE SCIENTIFIC LLC 122021-9

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA Female