BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHOS DELTA

    MDR report key: 18630228 · Received February 2, 2024

    Report

    Report Number
    1000391282-2024-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 2, 2024
    Manufacturer
    MILESTONE SRL
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TECHNICIAN USED THE PATHOS DELTA TISSUE PROCESSOR IN ORDER TO PREPARE THE TISSUE TO BE DIAGNOSED. THE PROTOCOL SELECTED WAS A MODIFIED PROTOCOL DEVELOPED BY THE LABORATORY PERSONNEL FOR 1MM THICKNESS (CUSTOMIZED). THE CUSTOMIZED PROTOCOL IN PAST WAS NOTED BY APPLICATION SPECIALISTS FROM OUR US-AGENT AS INADEQUATE. THE PROCESS TERMINATED WITHOUT ANY WARNING FROM THE PATHOS DELTA TISSUE PROCESSOR, ONE SPECIMEN WAS NOT ADEQUATELY PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535313 PATHOS DELTA PROCESSOR, TISSUE, AUTOMATED IEO MILESTONE SRL 66001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown