BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 13978855 · Received April 1, 2022

    Report

    Report Number
    3004032053-2022-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 19, 2022
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740189914
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR HDL TEST RESULTS THAT WERE MISMATCHED WITH LDH RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND LABELING REVIEW. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. THE INVESTIGATION INDICATED THAT THE UNEXPECTED BEHAVIOR OF THE MIDDLEWARE WAS DUE TO AN INCORRECT CONFIGURATION OF THE TEST-CHANNEL ASSOCIATION IN THE ANALYZER SECTION PERFORMED DURING THE SYSTEM INSTALLATION AND CONFIGURATION PHASE. THE INCONSISTENCY OF TEST RESULTS BETWEEN THE MIDDLEWARE AND THE ABBOTT INSTRUMENTS WAS DUE TO A MISCONFIGURATION OF THE HDL ASSAY CODE THAT WAS CONFIGURED USING THE LDH ASSAY CODE INSTEAD. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF ALINIQ AMS MIDDLEWARE, VERSION 2.12, WAS IDENTIFIED.H6 MEDICAL DEVICE PROBLEM CODE UPDATED FROM A20 TO A11.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A SOFTWARE ISSUE WITH THE ALINIQ AMS 2.12. THE CUSTOMER REPORTED THAT HDL TEST ORDERS SENT BY THE LIS WERE MISMATCHED ON THE AMS WITH THE LDH TEST. THE AMS WAS CONFIGURED FOR THE HDL ASSAY ON (B)(6) 2022. THE AMS AND ALINITY ANALYZER WERE CONNECTED TO THE LIS ON (B)(6) 2022 AND ONLY THE HDL ORDERS WERE AFFECTED FROM (B)(6). THE AMS CONFIGURATION WAS MODIFIED ON (B)(6) AND THE 241 SAMPLES WITH HDL ORDERS WERE RERUN TO CORRECT THE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824098 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 03R89-48 00380740189914

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown