BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM (REFURBISHED)

    MDR report key: 24736643 · Received March 30, 2026

    Report

    Report Number
    3005248192-2026-00031
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 18, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999047587
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 REFURBISHED, LIST 08N53-032, WHICH IS THE SAME/SIMILAR TO THE ALINITY M SYSTEM, LIST NUMBER 08N53-022 WHICH RECEIVED US FDA APPROVAL..

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS FOR ALINITY M HIGH RISK (HR) HPV AMP KIT WHILE RUNNING ON THE ALINITY M INSTRUMENT. SAMPLE ID (SID) (B)(6) WAS PROCESSED WITH ALINITY M HR HPV ASSAY ON (B)(6) 2026. DURING THE FIRST RUN, THE SAMPLE PRODUCED RESULT "NOT DETECTED". DUE TO LOW FRACTIONAL CYCLE NUMBER (FCN) VALUE OF CELLULAR CONTROL (CC) SIGNAL, THE SAMPLE WAS RE-PROCESSED THE SAME DAY WITH RESULT "HPV 16" AND "OTHER A" DETECTED. FIELD APPLICATION SPECIALIST (FAS) DOWNLOADED LOG FILES VIA ABBOTTLINK. VISUAL CURVE INSPECTION OF SID (B)(6) REVEALS LATE AMPLIFICATION OF CELLULAR CONTROL (CC) SIGNAL (COUMARIN FCN OF 33.06 WITH MAX RATION [MR] OF 0.27). HPV TARGETS WERE NOT AMPLIFIED. SAMPLE SID (B)(6) WAS RE-PROCESSED THE SAME DAY WITH RESULT "HPV 16" (C560 FCN OF 22.62 WITH MR OF 0.21) AND "OTHER A" (Q670 FCN OF 22.74 WITH MR OF 0.18). DURING TROUBLESHOOTING, PIPETTOR # 3 (PR3) BIAS WAS DISCOVERED ON 3-MAR-2026 FOR ALINITY M INSTRUMENT. RESULT FOR SAMPLE SID (B)(6) WAS RELEASED FROM THE LABORATORY AS "DETECTED" (FOR HPV 16 AND OTHER A TARGETS). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542673 ALINITY M SYSTEM (REFURBISHED) REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999047587

    Patients

    Seq Age Sex Outcome Treatment
    1