BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 23199558 · Received October 2, 2025

    Report

    Report Number
    3004032053-2025-00018
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 17, 2025
    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

    TECHNICAL INVESTIGATIONS PERFORMED BY THE ABBOTT ITS (INFORMATICS TECHNICAL SPECIALIST) REVEALED THAT A VALUE OF "0" HAD BEEN INADVERTENTLY CARRIED OVER FROM AN EARLIER QPL TEMPLATE VERSION, WHERE THE PARAMETER WAS DEFINED AS A NUMERIC (FLOAT) TYPE. IN THE UPDATED VERSION, THE PARAMETER WAS REDEFINED AS ALPHANUMERIC, ENABLING THE FIELD TO BE LEFT EMPTY (NULL) INSTEAD OF REQUIRING A DEFAULT NUMERIC VALUE. THE ABBOTT ITS RECOMPILED THE QPL USING THE CORRECTED TEMPLATE VALUE. NO DEFICIENCIES WERE IDENTIFIED FOR THE MIDDLEWARE. DEVICE HISTORY RECORD REVIEW REVEALED THAT THERE WERE NO NONCONFORMANCES OR POTENTIAL NONCONFORMANCES RELATED TO THE ISSUE DESCRIBED IN THE CURRENT COMPLAINT. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER¿S ISSUE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINIQ AMS SOFTWARE VERSION 3.02, LIST 03R89-63.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE ALINIQ AMS SOFTWARE BASE, VERSION 3.02. THE CUSTOMER STATED A PATIENT SAMPLE WITH AN ICTERIC INDEX OF > 711.999 SHOULD HAVE TRIGGERED THE HIL INDICES RULE TO GENERATE AND ICT COMMENT IN PLACE OF THE RESULT AND HOLD THE RESULT. THIS WAS NOT BEING PERFORMED FOR THE POTASSIUM TEST; THEREFORE, THE POTASSIUM RESULT WITH A HIGH ICTERIC INDEX WAS NOT BEING HELD, AND THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE ID PROVIDED WAS (B)(6), HOWEVER NO SPECIFIC TEST RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE ALINIQ AMS SOFTWARE BASE, VERSION 3.02. THE CUSTOMER STATED A PATIENT SAMPLE WITH AN ICTERIC INDEX OF > 711.999 SHOULD HAVE TRIGGERED THE HIL INDICES RULE TO GENERATE AND ICT COMMENT IN PLACE OF THE RESULT AND HOLD THE RESULT. THIS WAS NOT BEING PERFORMED FOR THE POTASSIUM TEST; THEREFORE, THE POTASSIUM RESULT WITH A HIGH ICTERIC INDEX WAS NOT BEING HELD, AND THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE ID PROVIDED WAS (B)(6); HOWEVER, NO SPECIFIC TEST RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307841 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740202736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown