BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 20343220 · Received October 1, 2024

    Report

    Report Number
    3004032053-2024-00012
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    July 28, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740202736
    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

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND LABELING REVIEW. THROUGH THE INVESTIGATION IT WAS DETERMINED THAT RESULTS WERE BEING WRONGLY INTERPRETED DUE TO AN INCORRECT MEASUREMENT UNIT CONFIGURED IN THE AMS. THE UNIT AND CUTOFF VALUE WERE INCORRECT IN THE DATA COLLECTION WORKSHEET COMPLETED BEFORE INSTALLATION AND PROVIDED BY THE ENGINEER DURING THE SETUP OF AMS QUALITY PROGRAMMING LANGUAGE (QPL) RULES. THE ISSUE WAS CORRECTED BY EDITING THE QPL RULE ACCORDING TO THE CUSTOMER¿S REQUIREMENTS. AN AFFECTED SAMPLE WAS RERUN, AND THE CORRECT BEHAVIOR OF THE AMS WAS CONFIRMED. NO DEFICIENCY OF THE MIDDLEWARE WAS IDENTIFIED. A REVIEW OF LABELING ADDRESSES THE ISSUE UNDER REVIEW AND PROVIDES ADEQUATE INFORMATION HOW TO CONFIGURE RULES IN THE SMART RULES EDITOR (SRE) MODULE OF THE ALINIQ AMS MIDDLEWARE. A TICKET TRENDING REPORT WAS REVIEWED AND IDENTIFIED NO ADDITIONAL COMPLAINTS RELATED TO THE CURRENT COMPLAINT ISSUE. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINIQ AMS SOFTWARE (VERSION 3.02) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6). SECTION E1- PHONE NUMBER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT HBSAG RESULTS ARE BEING REPORTED AS NEGATIVE ON THE AMS WHEN, THEY ARE POSITIVE. THE AMS IS CONFIGURED IN S/CO WHERE THE CUTOFF IS >1, WHILE THE INSTRUMENT IS RELEASING THE RESULT IN IU/ML WHERE THE CUTOFF IS >0.05. THEREFORE, THE RESULTS ARE BEING INCORRECTLY INTERPRETED IN AMS, SINCE THE RULE WAS NOT CONFIGURED PROPERLY. SINCE THE INSTALLATION, RESULTS BETWEEN 0.06 AND 1 WERE INTERPRETED AS "NEGATIVE" (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.11, (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.22, (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.10, SAMPLE ID (B)(6) RESULT ON THE INSTRUMENT = REACTIVE, SHOWN AS NEGATIVE ON THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT HBSAG RESULTS ARE BEING REPORTED AS NEGATIVE ON THE AMS WHEN, THEY ARE POSITIVE. THE AMS IS CONFIGURED IN S/CO WHERE THE CUTOFF IS >1, WHILE THE INSTRUMENT IS RELEASING THE RESULT IN IU/ML WHERE THE CUTOFF IS >0.05. THEREFORE, THE RESULTS ARE BEING INCORRECTLY INTERPRETED IN AMS, SINCE THE RULE WAS NOT CONFIGURED PROPERLY. SINCE THE INSTALLATION, RESULTS BETWEEN 0.06 AND 1 WERE INTERPRETED AS "NEGATIVE" (B)(6) 2024, SAMPLE ID (B)(6) RESULT = 0.11. (B)(6) 2024, SAMPLE ID (B)(6) RESULT = 0.22. (B)(6) 2024, SAMPLE ID (B)(6) RESULT = 0.10. SAMPLE ID (B)(6) RESULT ON THE INSTRUMENT = REACTIVE, SHOWN AS NEGATIVE ON THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369308 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740202736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown