BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 23595958 · Received November 19, 2025

    Report

    Report Number
    3005248192-2025-00492
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 10, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M SYSTEM, LIST 08N53-002, WHICH IS ALSO US FDA APPROVED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A NONCONFORMANCE (NC)/CAPA HISTORY REVIEW, SERVICE HISTORY REVIEW, AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS AS FOLLOWS: CAPA / NON-CONFORMANCE REVIEW: A SEARCH OF NC/CAPA RECORDS WAS PERFORMED FOR ANY FOR INSTANCES RELATED TO A LEAK DUE TO A BROKEN RESERVOIR SENSOR, PN 56-190088-02, THAT WAS LEAKING FROM THE BOTTOM ON AN ALINITY M SYSTEM. THE QUERY DID NOT IDENTIFY ANY RELATED QUALITY RECORDS. SERVICE HISTORY REVIEW: THE SERVICE HISTORY REVIEW FOUND NO PRIOR SERVICE RECORD RELATED TO THE ISSUE UNDER INVESTIGATION. ON AUGUST 13, 2025, PRIOR TO THE LEAK EVENT, TECHNICAL SERVICE BULLETIN (TSB) 640-079 - ALINITY M INSTRUMENT FLOOR LINER INSTALLATION WAS IMPLEMENTED ON ALINITY M SYSTEM SN (B)(6). THE ALINITY M SYSTEM LINER, PN 56-270087, WAS INSTALLED UNDERNEATH THE ALINITY M SYSTEM AND DESIGNED TO MITIGATE THE OCCURRENCES OF LEAKS THAT SPREAD BEYOND THE INSTRUMENT FOOTPRINT. IMPLEMENTATION OF TSB 640-079 AND THE LINER INSTALLATION DOES NOT PREVENT OCCURRENCES OF LEAKS THAT SPREAD OUTSIDE THE INSTRUMENT FOOTPRINT; HOWEVER, AS A MITIGATION, REDUCTION IN LEAKS BEYOND THE INSTRUMENT FOOTPRINT IS EXPECTED. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST COMPLAINT TICKETS RELATED TO LEAK DUE TO BROKEN RESERVOIR SENSOR, PN 56-190088-02, THAT WAS LEAKING FROM THE BOTTOM ON AN ALINITY M SYSTEM, LN 08N53-02. COMPLAINT TRENDING WAS REVIEWED. AN ADVERSE TREND WAS NOT IDENTIFIED FOR THE ALINITY M SYSTEM LN 08N53-002. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE ALINITY M SYSTEM, LN 08N53-002.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A LEAK IN THE SYSTEM SOLUTIONS DRAWER OF THEIR ALINITY M SYSTEM. THE CUSTOMER REPORTED A SYSTEM SOLUTION LEAK ON THEIR ALINITY M INSTRUMENT. THEY REPORTED THAT THERE WAS VAPOR BARRIER SOLUTION ON THE FLOOR IN FRONT OF IN THE BACK OF THE INSTRUMENT AND ALSO IN THE SOLUTION DRAWER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND SAW THE LEAKED VAPOR BARRIER SOLUTION ON THE FLOOR AND IN THE SOLUTION DRAWER. THE FSE SAW THAT THE RESERVOIR WAS LEAKING. THE FSE CLEANED THE SOLUTION DRAWER AND FLOOR AND SAW THAT THE RESERVOIR SENSOR WAS BROKEN. THE RESERVOIR SENSOR AND RESERVOIR WERE REPLACED. THERE WAS NO REPORT OF INJURY OR ANY ACTUAL EXPOSURE TO THE LEAKED LIQUID. THERE WAS NO PATIENT INVOLVED AS THE LEAK WAS IDENTIFIED BY THE ALINITY M SYSTEM USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628284 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown