BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 21751073 · Received April 2, 2025

    Report

    Report Number
    3004032053-2025-00008
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 13, 2025
    Report Date
    May 9, 2025
    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 CONFIRMED A MISCONFIGURATION RULE RESPONSIBLE FOR MANAGING HIL TESTS IN LAB ORDERS TRANSFERRED FROM THE LABORATORY INFORMATION SYSTEM (LIS) TO THE AMS. THE CANCELLATION PARAMETER OF THE RULE WAS INADVERTENTLY ENABLED. THE LABORATORY USED TWO ANALYZERS (VISTA AND ALINITY CI) CONNECTED TO DIFFERENT MIDDLEWARE BUT INTERFACING WITH THE SAME LIS. WHEN SAMPLES WITH TESTS INITIALLY COMPLETED ON THE VISTA ANALYZER WERE MOVED TO THE ALINITY, THE LIS SENT CANCELLATION MESSAGES FOR THE TESTS ALREADY COMPLETED. THESE CANCELLATIONS TRIGGERED THE REMOVAL OF HIL TESTS FROM THE ORDERS AS A RESULT OF THE MISCONFIGURATION. THE ISSUE WAS RESOLVED THROUGH A CONFIGURATION RULE AND VERIFIED CORRECT OPERATION AT THE CUSTOMER SITE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINIQ AMS WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINIQ AMS WILL CANCEL THE HIL INDEX (HEMOLYSIS, ICTERIC, LIPEMIA) ORDER ON SAMPLES THAT HAD A CORRESPONDING ASSAY THAT WAS CANCELED. THIS WAS IDENTIFIED WHEN THE CUSTOMER FOUND MULTIPLE SAMPLES THAT HAD NO HIL MEASUREMENTS COMPLETED ON THEM. AFTER FURTHER REVIEW, AN ALINIQ AMS RULE WAS CONFIGURED INCORRECTLY. THIS RULE IS RESPONSIBLE FOR ADDING HIL ORDERS TO CERTAIN DEFINED TESTS THAT THE LIS SENDS TO THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINIQ AMS WILL CANCEL THE HIL INDEX (HEMOLYSIS, ICTERIC, LIPEMIA) ORDER ON SAMPLES THAT HAD A CORRESPONDING ASSAY THAT WAS CANCELED. THIS WAS IDENTIFIED WHEN THE CUSTOMER FOUND MULTIPLE SAMPLES THAT HAD NO HIL MEASUREMENTS COMPLETED ON THEM. AFTER FURTHER REVIEW, AN ALINIQ AMS RULE WAS CONFIGURED INCORRECTLY. THIS RULE IS RESPONSIBLE FOR ADDING HIL ORDERS TO CERTAIN DEFINED TESTS THAT THE LIS SENDS TO THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264039 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740212575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown