BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 18369577 · Received December 20, 2023

    Report

    Report Number
    3004032053-2023-00030
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 28, 2023
    Report Date
    February 6, 2024
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740145118
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INTO THE ISSUE REVEALED THAT THE ALINIQ AMS SPE (SAMPLE PRESENTATION ERRORS) RULE DID NOT BLOCK TESTS UPDATED BY THE QUALITY PROGRAMMING LANGUAGE (QPL) RULES. THIS ALLOWED INCORRECT RESULTS TO BE CALCULATED AND AUTO VALIDATED. THE ISSUE WAS INVESTIGATED BY THE ALINIQ AMS TECHNICAL TEAM, AND THE TECHNICAL GROUP IDENTIFIED TWO SCENARIOS IN WHICH THE CUSTOMER HAD CONFIGURED A CUSTOM RULE LOGIC, WHICH INTERACTED UNEXPECTEDLY WITH THE EXISTING STANDARD ERROR HANDLING RULE LOGIC. THIS ALLOWED SEROLOGY SAMPLES WITH SPE TO BE CALCULATED AND RELEASED. A RESOLUTION WAS PROPOSED THAT INVOLVED ADJUSTING THE CUSTOM LOGIC TO KEEP THE CALCULATED RESULTS BLOCKED FOR SAMPLES REQUIRING PRESENTATION ERROR HANDLING. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THE CURRENT ISSUE. REVIEW OF CURRENT LABELLING PROVIDES ADEQUATE INFORMATION TO THE CUSTOMER REGARDING THE SETUP, CONFIGURATION AND MANAGEMENT OF TEST RESULTS AND RULES ON THE ALINIQ AMS MIDDLEWARE (VERSION 2.09). TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. BASED ON THE INVESTIGATION, NO MALFUNCTION OR DEFICIENCY FOR 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE ALINIQ AMS (ANALYZER MANAGEMENT SYSTEM) SPE RULE IS NOT BLOCKING TESTS UPDATED BY QPL RULES RESULTING IN PATIENT SAMPLES BEING REPORTED INCORRECTLY. THE SPE ERRORS ARE CAUSING INCORRECT RESULTS TO BE CALCULATED AND AUTO-VALIDATED. THE ERROR IS CAUSING QUALITATIVE INTERPRETATIVE RESULTS TO BE INCORRECTLY CALCULATED AS QNDET AND THEN AUTO-VALIDATED. THE CUSTOMER PROVIDED THE FOLLOWING TWO PATIENT SID EXAMPLES: (B)(6). NO SPECIFIC PATIENT DATA WAS PROVIDED. THE CUSTOMER REQUESTED THAT A RULE BE PUT IN PLACE TO BLOCK ALL RESULTS ON A SAMPLE WHEN ANY TEST ON THE SAMPLE HAS AN SPE ERROR. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE ALINIQ AMS (ANALYZER MANAGEMENT SYSTEM) SPE RULE IS NOT BLOCKING TESTS UPDATED BY QPL RULES RESULTING IN PATIENT SAMPLES BEING REPORTED INCORRECTLY. THE SPE ERRORS ARE CAUSING INCORRECT RESULTS TO BE CALCULATED AND AUTO-VALIDATED. THE ERROR IS CAUSING QUALITATIVE INTERPRETATIVE RESULTS TO BE INCORRECTLY CALCULATED AS QNDET AND THEN AUTO-VALIDATED. THE CUSTOMER PROVIDED THE FOLLOWING TWO PATIENT SID EXAMPLES: (B)(6) AND (B)(6). NO SPECIFIC PATIENT DATA WAS PROVIDED. THE CUSTOMER REQUESTED THAT A RULE BE PUT IN PLACE TO BLOCK ALL RESULTS ON A SAMPLE WHEN ANY TEST ON THE SAMPLE HAS AN SPE ERROR. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153920 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740145118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown