BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 25059442 · Received May 1, 2026

    Report

    Report Number
    3005248192-2026-00041
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INTERNTIONALLY USING THE ALINITY M SYSTEM, LIST 08N53-002, WHICH IS ALSO US FDA APPROVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE CHLAMYDIA TRACHOMATIS (CT) TARGET WHEN RUNNING THE ALINITY M STI ASSAY ON THE ALINITY M SYSTEM. DURING INITIAL TESTING ON (B)(6) 2026, SAMPLE ID (B)(6) HAD THE FOLLOWING RESULTS: CHLAMYDIA TRACHOMATIS (CT): NOT DETECTED NEISSERIA GONORRHOEAE (NG): DETECTED AT FRACTIONAL CYCLE NUMBER (FCN) 30.64 CELLULAR CONTROL (CC): FCN 31.38 INTERNAL CONTROL (IC): FCN 29.83. REFLEX TESTING WAS DONE ON ANOTHER NON-ABBOTT INSTRUMENT DUE TO THE NG BEING DETECTED. CT WAS DETECTED AT CYCLE THRESHOLD 36.6. NG DETECTED AT CYCLE THRESHOLD 28.2. SAMPLE WAS RETESTED ON THE SAME DAY WITH THE FOLLOWING RESULTS: CT: DETECTED AT FCN 33.43 NG: DETECTED AT FCN 31.03 CC: FCN 31.86 IC: FCN 29.34. AMPLIFICATION CURVE ANALYSIS FOUND THAT THE INITIAL CURVE WAS VALID WITH NO ANOMALIES FOUND. AN ERRATIC DILUENT FLOAT SENSOR WAS DETECTED, INDICATING A DILUENT DISPENSING ISSUE. LOCAL TEAM HAS BEEN NOTIFIED ON THIS ISSUE FOR FURTHER ACTION. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LAB. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84522 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1