BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 24544175 · Received March 9, 2026

    Report

    Report Number
    3004032053-2026-00004
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740212575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IDENTIFIED THE ISSUE STEMS FROM HOW THE VALIDATION RULE WAS ORIGINALLY CONFIGURED. THE CUSTOMER¿S EXISTING HPV RULE WAS CONFIGURED TO EVALUATE HPV ¿OTHER A¿ AND ¿OTHER B¿ AS SEPARATE RESULTS. HOWEVER, IN THE ALINIQ AMS, THESE RESULTS ARE CONSOLIDATED INTO A SINGLE COMBINED OUTPUT. THIS MISMATCH CONFLICTED WITH THE RULE LOGIC, WHICH ATTEMPTED TO EVALUATE MULTIPLE DISCRETE OUTCOMES AGAINST THE MERGED RESULT, CAUSING THE SYSTEM TO INCORRECTLY INTERPRET THE OUTCOME AS NEGATIVE. A QPL ADJUSTMENT WAS IMPLEMENTED TO ALIGN THE RULE LOGIC WITH THE COMBINED HPV OTHER OUTPUT, ENSURING CORRECT INTERPRETATION AND CONSISTENT RESULT GENERATION. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINIQ AMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE CURRENT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE CURRENT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, THE ALINIQ AMS MIDDLEWARE IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINIQ AMS MIDDLEWARE WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    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 OBSERVED THE ALINIQ AMS REPORTED THE HPVOTHER, WHICH IS A COMBINED PLACEHOLDER FOR THE HPV OTHER A AND HPV OTHER B, AS NEGATIVE RESULT EVEN THOUGH THE HPV RESULT WAS OTHER HR HPV A, SHOULD HAVE RESULTED AS POSITIVE. HPV ¿OTHER¿ RESULTS ARE CONSOLIDATED INTO A SINGLE OUTPUT TEST (HPVOTHER), WHICH CONFLICTED WITH THE EXISTING VALIDATION RULE BY EVALUATING MULTIPLE OUTCOMES (OTHER A AND OTHER B) AGAINST ONE COMBINED RESULT. ALL PATIENT RESULTS WERE BLOCKED AND HELD IN THE LIS AND NO RESULTS WERE RELEASED OUT OF THE LABORATORY. A QPL ADJUSTMENT WAS IMPLEMENTED TO ENSURE THE RULE CORRECTLY INTERPRETS THE COMBINED HPV OTHER RESULTS AND PRODUCES A CONSISTENT OUTCOME. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THE ALINIQ AMS REPORTED THE HPVOTHER, WHICH IS A COMBINED PLACEHOLDER FOR THE HPV OTHER A AND HPV OTHER B, AS NEGATIVE RESULT EVEN THOUGH THE HPV RESULT WAS OTHER HR HPV A, SHOULD HAVE RESULTED AS POSITIVE. HPV ¿OTHER¿ RESULTS ARE CONSOLIDATED INTO A SINGLE OUTPUT TEST (HPVOTHER), WHICH CONFLICTED WITH THE EXISTING VALIDATION RULE BY EVALUATING MULTIPLE OUTCOMES (OTHER A AND OTHER B) AGAINST ONE COMBINED RESULT. ALL PATIENT RESULTS WERE BLOCKED AND HELD IN THE LIS AND NO RESULTS WERE RELEASED OUT OF THE LABORATORY. A QPL ADJUSTMENT WAS IMPLEMENTED TO ENSURE THE RULE CORRECTLY INTERPRETS THE COMBINED HPV OTHER RESULTS AND PRODUCES A CONSISTENT OUTCOME. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603377 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740212575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown