BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHOS DELTA

    MDR report key: 18543069 · Received January 19, 2024

    Report

    Report Number
    1000391282-2024-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    October 6, 2023
    Report Date
    January 19, 2024
    Manufacturer
    MILESTONE SRL
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICIAN OF LABORATORY INFORMED THE APPLICATION SPECIALIST IN U.S. AGENT OFFICE REPORTING THAT THEY HAD TISSUE NOT PROCESSED WELL. THE CONTROL OF THE DEVICE SHOWED THAT THE OPERATOR CHANGED THE REAGENT ISOPROPANOL IN TANK NR. 7 BEFORE THE PROCESS. THE CONCENTRATION DETECTED BY THE OPERATOR OF LAHEY WAS OF APPROXIMATELY OF 80%, INSTEAD THE CONCENTRATION OF THE REAGENT SHOULD BE AT LEAST MORE THAN 98%. SEEMS A REAGENT MISTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247771 PATHOS DELTA TISSUE PROCESSOR IEO MILESTONE SRL 66001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown