BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASS SPECTROMETER, CLINICAL USE

    MDR report key: 23671079 · Received November 28, 2025

    Report

    Report Number
    23671079
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 30, 2025
    Manufacturer
    REVVITY, INC.
    Product Code
    DOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO HARM TO PATIENT. INSTRUMENT DOWN, CALLED FOR SERVICE. NO RESPONSE FOR SEVERAL DAYS. MULTIPLE CALLS PLACED BY LAB AND MANAGER TO COMPANY WITH MESSAGES LEFT FOR SERVICE MANAGER WHO FINALLY RETURNED CALL 7 DAYS LATER. AT THIS TIME PROMISED THAT SERVICE WOULD BE COMPLETE ON FRIDAY [REDACTED]. SERVICE DID ARRIVE AND REPAIRED TO THE POINT THAT WE WERE ABLE TO COMPLETE LIMITED TESTING ON PATIENTS. MONDAY [REDACTED] - 3 DAYS LATER, INSTRUMENT WAS DOWN AGAIN. CALLED FOR SERVICE AND NO RETURN CALL TO DATE. CALL PLACED AND EMAIL SENT TO SERVICE MANAGER AGAIN TODAY. TESTING IS DOWN FOR TOXICOLOGY TESTS FOR METALS. WE ARE BACKLOGGED ON SPECIMENS >125 PATIENTS AND SENDING OUT LIMITED SAMPLES BY THE DAY. INSTRUMENT MANUFACTURER IS PERKIN ELMER MODEL NEXION 350X SERIAL NUMBER IS [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079515 MASS SPECTROMETER, CLINICAL USE DOP REVVITY, INC. NEXION 350X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown