BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 23873139 · Received December 22, 2025

    Report

    Report Number
    3004032053-2025-00024
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 9, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740202736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINIQ AMS SOFTWARE (VERSION 3.02) IDENTIFIED NO RELATED TRENDS FOR THE CURRENT COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONTAINED ADEQUATE INFORMATION TO CONFIGURE THE AMS MIDDLEWARE AND CONFIRMED IT IS NOT RELATED, NOR CONTRIBUTING TO THE ISSUE IDENTIFIED IN THE CURRENT COMPLAINT. IN THIS CASE, THE SYSTEM LOGS SHOW THAT SAMPLE (B)(6) PRODUCED A VALIDATED RESULT OF 65.1 G/L, AND THE ANALYZER¿S CONFIGURATION CORRECTLY BLOCKED RERUN RESULTS FROM BEING ACCEPTED FOR TESTS THAT WERE ALREADY CLOSED. BECAUSE AMS ONLY ACCEPTS RERUNS WHEN A TEST IS MANUALLY REOPENED OR TRIGGERED BY PREDEFINED RULES, THE SUBSEQUENT RERUN VALUES (149, 148, 149, 148) WERE NEVER SENT TO AMS. ADDITIONALLY, AMS AUDIT LOGS SHOWED NO TRANSMISSION ISSUES OR ANY USER ACTIONS TO REOPEN THE TEST FOR RE-RUNS. ALL AVAILABLE EVIDENCE INDICATES THAT THE MIDDLEWARE FUNCTIONED PROPERLY AT THE CUSTOMER SITE. BASED ON THE INVESTIGATION, ALINIQ AMS SOFTWARE (VERSION 3.02) IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. SEE RELATED MANUFACTURER REPORT 2919069-2025-00053.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SEE RELATED MANUFACTURER REPORT 2919069-2025-00053.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED HEMOGLOBIN RESULT RECEIVED IN THE ALINIQ AMS BASE SOFTWARE FOR ONE PATIENT SAMPLE. THE FOLLOWING EVENTS OCCURRED FOR SAMPLE ID (B)(6): ORIGINAL HEMOGLOBIN RESULT WAS RECEIVED IN ALINIQ AMS BASE SOFTWARE AS 65.1 G/L (6.51 G/DL) AND THE FIRST RERUN RESULTS FOR HEMOGLOBIN WAS 149 WHICH DISPLAYED IN AMS. THE SUBSEQUENT FOUR RERUNS GENERATED RESULTS OF 149,148, 149 AND 148 G/L (14.9, 14.8, 14.9, AND 14.8 G/DL) AND THESE RESULTS WERE GENERATED ON THE ANALYZER, HOWEVER, THESE RESULTS DID NOT COME ACROSS TO AMS. THE RERUN RESULTS ON AMS CAME UP AS 65 FOUR TIMES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED HEMOGLOBIN RESULT RECEIVED IN THE ALINIQ AMS BASE SOFTWARE FOR ONE PATIENT SAMPLE. THE FOLLOWING EVENTS OCCURRED FOR SAMPLE ID (B)(6). ORIGINAL HEMOGLOBIN RESULT WAS RECEIVED IN ALINIQ AMS BASE SOFTWARE AS 65.1 G/L (6.51 G/DL) AND THE FIRST RERUN RESULTS FOR HEMOGLOBIN WAS 149 WHICH DISPLAYED IN AMS. THE SUBSEQUENT FOUR RERUNS GENERATED RESULTS OF 149,148, 149 AND 148 G/L (14.9, 14.8, 14.9, AND 14.8 G/DL) AND THESE RESULTS WERE GENERATED ON THE ANALYZER, HOWEVER, THESE RESULTS DID NOT COME ACROSS TO AMS. THE RERUN RESULTS ON AMS CAME UP AS 65 FOUR TIMES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255697 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL OCN02295-801-00 00380740202736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown