BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 22923430 · Received August 29, 2025

    Report

    Report Number
    1319681-2025-00040
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE VITROS OPERATOR BURNED ONE OF HER FINGERS WHILE CLEANING THE SECONDARY TIP SEALER. THE BURN DEVELOPED A BLISTER, WHICH INDICATES THE BURN WAS AT A MINIMUM A 2ND DEGREE BURN. THE VITROS OPERATOR RAN THE BURNED FINGER UNDER COLD WATER BUT DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION. THE VITROS OPERATOR STATED THE BURNED FINGER WAS COMPLETELY HEALED AND THERE WAS NO SERIOUS INJURY OR PERMANENT IMPAIRMENT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    WHILE INTERACTING WITH THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO RESOLVE AN ISSUE WITH THE SECONDARY TIP SEALER, A VITROS OPERATOR BURNED HER FINGER ON THE SECONDARY TIP SEALER. THE ORTHO TSC CONTACTED THE VITROS OPERATOR APPROXIMATELY 2 WEEKS AFTER THE EVENT AND THE VITROS OPERATOR STATED THE BURN ON THE FINGER WAS COMPLETELY HEALED AND THERE WAS NO SERIOUS INJURY OR PERMANENT IMPAIRMENT AS A RESULT OF THIS EVENT. PER A MEDICAL CONSULTATION WITH AN ORTHO MEDICAL SAFETY OFFICER (MSO), THOUGH THE OPERATOR DEVELOPED A SECONDARY BURN DUE TO THE FORMATION OF BLISTERS, THEY DID NOT RECEIVE AN ESCALATED MEDICAL TREATMENT TO PREVENT PERMANENT IMPAIRMENT OR PERMANENT DAMAGE TO A BODY STRUCTURE OR FUNCTION. THERE WAS COMPLETE BURN RESOLUTION AT APPROXIMATELY TWO WEEKS, AND THERE IS NO ANTICIPATED PERMANENT SERIOUS DETERIORATION OF THE OPERATOR'S HEALTH. NO FURTHER PATIENT HARM IS EXPECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164240 VITROS XT 7600 INTEGRATED SYSTEM IN-VITRO DIAGNOSTICS JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown