BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 23437511 · Received October 31, 2025

    Report

    Report Number
    3004032053-2025-00022
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740200169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IDENTIFIED THAT THE ISSUE STEMMED FROM AN INCOMPLETE ORDER ENTRY IN THE CUSTOMER¿S LABORATORY INFORMATION SYSTEM (LIS). THE FIRST ORDER (SID (B)(6) WAS NEVER FULLY COMPLETED BEFORE THE SECOND ORDER (SID (B)(6) WAS CREATED. WHEN THE LIS TRANSMITTED SID (B)(6), IT ENDED THE MESSAGE WITH AN <ETB>, CAUSING THE AMS HOST DRIVER TO EXPECT ADDITIONAL DATA. INSTEAD, THE LIS SENT A NEW PATIENT RECORD. DUE TO THE INCOMPLETE ORDER ENTRY AND THE <ETB> MESSAGE TERMINATION, THE AMS SYSTEM CARRIED OVER THE DEMOGRAPHICS FROM THE FIRST SID TO THE SECOND. A REVIEW OF TRACKING AND TRENDING OF THE ALINIQ DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE LABELING INDICATED IT IS NOT RELATED, NOR CONTRIBUTING TO THE ISSUE IDENTIFIED IN THE CURRENT COMPLAINT. BASED ON THE INVESTIGATION THE ALINIQ AMS IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINIQ AMS, SOFTWARE (VERSION 3.01) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT THE ALINIQ AMS TRANSMITTED A DIFFERENT PATIENT NAME TO THE ANALYZER COMPARED TO THE BARCODE ON THE SAMPLE. THE CUSTOMER CONFIRMED THAT THE PATIENT'S NAME IN THE LIS MATCHED THE PATIENT'S NAME ON THE BARCODE. THIS OCCURRED WHILE TWO SAMPLES (SIDS (B)(6), WERE RUN AT THE SAME TIME. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT THE ALINIQ AMS TRANSMITTED A DIFFERENT PATIENT NAME TO THE ANALYZER COMPARED TO THE BARCODE ON THE SAMPLE. THE CUSTOMER CONFIRMED THAT THE PATIENT NAME IN THE LIS MATCHED THE PATIENT'S NAME ON THE BARCODE. THIS OCCURRED WHILE TWO SAMPLES (SIDS (B)(6), WERE RUN AT THE SAME TIME. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906484 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL OCN03777-801 00380740200169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown