BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASS SPECTROMETER, CLINICAL USE

    MDR report key: 24640970 · Received March 19, 2026

    Report

    Report Number
    3009715051-2026-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 20, 2026
    Report Date
    March 18, 2026
    Manufacturer
    AB SCIEX PTE. LTD.
    Product Code
    DOP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INITIALLY REPORTED AS "OVERHEATED SOURCE AND OPEN FLAME OBSERVED". AN INITIAL INVESTIGATION WAS INITIATED BASED ON CUSTOMER COMMUNICATION/INTERVIEWS: SIMILAR SAMPLES WERE RUN PREVIOUSLY ON THIS INSTRUMENT WITH NO REPORTED INCIDENT. BEFORE THIS PARTICULAR RUN, THE FITTING WAS CHECKED AND THERE WAS NO LOOSENESS OF THE CAPILLARY OBSERVED. NO SOLVENT LEAKS WERE NOTICED DURING THE APPLICATION OF THE SAMPLE. WHEN THE TECHNICIAN NOTICED THE FLAME, THE PEEK TUBING WAS DETACHED AT THE ION SOURCE INTERFACE AND SOLVENT WAS DRIPPING ONTO THE FLOOR AWAY FROM THE ION SOURCE. THE TECHNICIAN PUT THE INSTRUMENT INTO STANDBY MODE, AT WHICH POINT THE FLAME STOPPED. FURTHER MANUFACTURER INVESTIGATION IS PENDING RECEIPT OF THE MALFUNCTIONED COMPONENT.

    Description of Event or Problem · 0

    COMPLAINT OPENED TO ADDRESS FLAME OBSERVED ON THE [ION] SOURCE OF THE MASS SPECTROMETER. A FIELD SERVICE EMPLOYEE EVALUATED THE INSTRUMENT AND CONFIRMED THAT THE INCIDENT WAS LIMITED TO THE ION SOURCE ASSEMBLY. BURN MARKS (DISCOLOURATION) AND SLIGHT DEFORMATION TO THE TOP OF THE PROBE OF THE ION SOURCE ASSEMBLY WERE OBSERVED. NO SUBSTANTIAL DAMAGE OCCURRED TO THE REST OF THE INSTRUMENT OR TO THE CUSTOMER ENVIRONMENT. THE [ELECTRODE ADJUSTMENT] NUT WAS REPLACED, AND SUBSEQUENT TESTING WITH THE REPLACEMENT WAS PERFORMED AND CONFIRMED THAT THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704429 MASS SPECTROMETER, CLINICAL USE DOP AB SCIEX PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other