BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 23512363 · Received November 10, 2025

    Report

    Report Number
    3005248192-2025-00478
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 20, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE INVESTIGATION HAS NOT BEEN INITIATED, AS THE CUSTOMER HAS INDICATED THAT THEY DO NOT BELIEVE THE INSTRUMENT CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. BASED ON THE CUSTOMER'S ACCOUNT AND THE ABBOTT SERVICE PERSONNEL, THE ISSUE APPEARS TO BE UNRELATED TO INSTRUMENT PERFORMANCE. GIVEN THE ABSENCE OF ANY ALLEGATION OR EVIDENCE SUGGESTING THE INSTRUMENT WAS INVOLVED, THE EVENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE INCIDENT. THIS MDR IS NO LONGER CONSIDERED A REPORTABLE EVENT.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED MISQUANTITATION HIGH ON A CMV WHOLE BLOOD (WB) SAMPLE ON THE ALINITY M SYSTEM WHILE RUNNING THE ALINITY M CMV WB ASSAY. THE PATIENT GETS TESTED FOR MONITORING EVERY 2 DAYS AND RECEIVED A RESULT THAT DID NOT MATCH. THE OUTLIER IS SAMPLE ID (SID) (B)(6) TAKEN ON (B)(6) 2025, RESULT OF 151824 IU/ML (= 5.18 LOG IU/ML) AS THE OTHER RESULTS EVEN BETWEEN INSTRUMENTS REMAINED RATHER STABLE (BETWEEN 3.87 AND 4.52 LOG IU/ML). THE CUSTOMER RAN SAMPLE 1 ((B)(6) TAKEN ON (B)(6)) TOGETHER WITH THE SAMPLE 2 COLLECTED ON (B)(6) 2025 (PROCESSED UNDER SAMPLE ID (B)(6) ON ALINITY M 1279) AND THE RESULTS DIFFERED SO MUCH (7829 IU/ML TO 151824 IU/ML) THAT THE CUSTOMER DID NOT BELIEVE THE RESULTS AS THE INCREASE WAS TOO HIGH. THE CUSTOMER TESTED BOTH SAMPLES AGAIN (PRIMARY TUBES ARE STORED IN FRIDGE, ALIQUOT IS TAKEN FOR TESTING AND MIXED PRIOR TO LOADING ONTO INSTRUMENT) TO CONFIRM THE RESULTS AND GOT THE FOLLOWING RESULTS: SAMPLE 1 ON ALINITY M SERIAL NUMBER (SN) (B)(6) SID RESULT (IU/ML) (B)(6) 33323 SAMPLE 1 ON ALINITY M SERIAL NUMBER (SN) (B)(6) SID RESULT (IU/ML) (B)(6) 7829 (B)(6) 7482 ALL OF THESE RESULTS HAVE A MAXIMUM OF 0.02 LOG IU/ML ON SN (B)(6), BUT 0.65 LOG IU/ML BETWEEN THE TWO DIFFERENT ALINITY M'S, WHICH THE CUSTOMER FINDS CONCERNING AS THEY DOUBT THE REPRODUCIBILITY OF THE RESULTS. SAMPLE 2 PROCESSED ON ALINITY M SN (B)(6). SID RESULT (IU/ML). (B)(6) 151824. (B)(6) 21788. SAMPLE 2 PROCESSED ON ALINITY M SN (B)(6). SID. RESULT (IU/ML). (B)(6) 18866. SAMPLE 2 HAD A 0.06 LOG IU/ML DIFFERENCE BETWEEN INSTRUMENTS AND RESULT OF 151824 WITH 5.18 LOG IU/ML IS THE OUTLIER. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854156 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown