BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHADIA 1000 INSTRUMENT

    MDR report key: 22360018 · Received June 30, 2025

    Report

    Report Number
    3004973408-2025-00001
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 27, 2025
    Manufacturer
    PHADIA AB
    Product Code
    DHB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    US FIELD SERVICE ENGINEER (FSE) WAS AT A CUSTOMER SITE FOR A SERVICE VISIT. WHILE REPLACING THE VACUUM PUMP ON PHADIA 1000 INSTRUMENT, THE INSTRUMENT WASTE WAS SPLASHED INTO HIS EYES FROM THE WASTE LINE. THE ENGINEER FLUSHED HIS EYES WITH WATER AND AFTER TALKING TO HIS MANAGER, HE FLUSHED HIS EYES FOR AN ADDITIONAL PERIOD OF TIME AS PER HIS MANAGER'S RECOMMENDATION. THE ENGINEER THEN WENT TO AN URGENT CARE FACILITY AND RECEIVED AN EYE EXAM AND BLOOD TEST (HEPATITIS, HIV, ETC.). THE ENGINEER NEEDS TO DO A FOLLOW-UP SCREENING IN ONE MONTH. THIS IS THE FIRST OCCURRENCE OF THIS TYPE OF EVENT. THE COMPLAINT INVESTIGATION IS ONGOING AND NO MALFUNCTION OF THE PHADIA INSTRUMENT HAS BEEN CONFIRMED TILL DATE. THE LIQUID WASTE GENERATED BY PHADIA INSTRUMENTS MAY CONTAIN THE FOLLOWING SUBSTANCES AT LOW CONCENTRATIONS: CMIT/MIT (KATHON), SODIUM AZIDE, SODIUM CARBONATE, SODIUM HYDROXIDE, ALKYL (C12-16) DIMETHYLBENZYLAMMONIUM CHLORIDE, 2-AMINOETHANOL. IN ADDITION TO THE ABOVE SUBSTANCES, IT MAY ALSO CONTAIN HUMAN SERUM.

    Description of Event or Problem · 0

    US FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE FOR A SERVICE VISIT. WHILE REPLACING THE VACUUM PUMP, THE INSTRUMENT WASTE WAS SPLASHED INTO HIS EYES FROM THE WASTE LINE. THE ENGINEER FLUSHED HIS EYES WITH WATER AND AFTER TALKING TO HIS MANAGER, HE FLUSHED HIS EYES FOR AN ADDITIONAL PERIOD OF TIME AS PER HIS MANAGER'S RECOMMENDATION. THE ENGINEER THEN WENT TO AN URGENT CARE FACILITY AND RECEIVED AN EYE EXAM AND BLOOD TEST (HEPATITIS, HIV, ETC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756257 PHADIA 1000 INSTRUMENT PHADIA LABORATORY INSTRUMENT DHB PHADIA AB

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention