BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIEX TRIPLE QUAD 6500+ SYSTEM

    MDR report key: 25255709 · Received May 22, 2026

    Report

    Report Number
    3009715051-2026-00002
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 22, 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

    COMPLAINT INVESTIGATION IS ONGOING. THE AFFECTED INSTRUMENT IS CURRENTLY IN TRANSIT TO THE MANUFACTURER FOR FURTHER EVALUATION AND INVESTIGATION. THE PRODUCT INVOLVED IN THE INCIDENT IS NOT A MEDICAL DEVICE. HOWEVER, IT CAN BE CONSIDERED TO BE SIMILAR TO SCIEX'S MARKETED MASS SPECTROMETERS AS THEY SHARE DESIGN CHARACTERISTICS AND COMPONENTS. AS A RESULT, THE MALFUNCTION MAY OCCUR WITH SCIEX'S MEDICAL DEVICES WITH A REMOTE PROBABILITY OF A SERIOUS INJURY.

    Description of Event or Problem · 0

    WHILE RUNNING A METHOD, A SMALL FLASH FIRE OCCURRED (AS INDICATED BY THE DAMAGE SUSTAINED TO THE INSTRUMENT PROBE) IN THE SOURCE AREA AROUND THE PROBE ON THE SCIEX TRIPLE QUAD 6500+ MASS SPECTROMETER SYSTEM. THE SYSTEM CONTINUED OPERATING AND COMPLETED THE BATCH WITHOUT GENERATING A FAULT OR ERROR. NO INJURIES OR HARM WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509629 SCIEX TRIPLE QUAD 6500+ SYSTEM MASS SPECTROMETER DOP AB SCIEX PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other