BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 21525123 · Received March 5, 2025

    Report

    Report Number
    3004032053-2025-00006
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 8, 2025
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. NEW PATIENT INFORMATION ADDED TO SECTION A; UPDATED SECTION B5.

    Additional Manufacturer Narrative · 0

    THE CMV AVIDITY TEST CONSISTS OF THREE SUB-ASSAYS WITH DIFFERENT ASSAY CODES. THE DILUTION REQUIRED FOR THESE ASSAYS DEPENDS ON THE RESULT OF THE CMV IGG TEST WHICH IS PERFORMED FIRST. IF AN INSTRUMENT ERROR OCCURS, THE QPL FAILS TO SEND THE CORRECT DILUTION, CAUSING THE CMV AVIDITY TEST TO BE MEASURED WITH A STRAIGHT DILUTION LEADING TO INACCURATE RESULTS. AN ABBOTT REPRESENTATIVE IMPLEMENTED NEW ONDOWNLOAD QPL AT THE CUSTOMER SITE TO AUTOMATICALLY DELETE THE AVIDITY TEST CHANNELS IF THERE IS NO RESULT OR AN INCORRECT RESULT FOR THE CMV IGG TEST. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER¿S ISSUE AND CONFIRMED THAT LABELLING IS NOT RELATED, NOR CONTRIBUTING TO THE ISSUE IDENTIFIED IN THE CURRENT COMPLAINT. A 12-MONTH REVIEW OF SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE CURRENT COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION NO DEFICIENCY RELATED TO THE CURRENT COMPLAINT ISSUE 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 REPORTED AN ISSUE WITH THE AMS SOFTWARE. IF THERE IS AN INSTRUMENT/ASSAY ISSUE DUE TO THE CMV IGG NOT BEING MEASURED CORRECTLY / ERROR MESSAGE: RE-PROCESSING OF TUBE WILL BEGIN TO RERUN THE CMV IGG. THE CMV AVIDITY TESTS CAN BE SENT TO THE ALINITY FOR TESTING BEFORE A CORRECT DILUTION CAN BE APPLIED RESULTING IN THE CMV AVIDITY TEST BEING MEASURED IN STRAIGHT DILUTION INSTEAD OF THE APPROPRIATE DILUTION BASED ON THE CMV IGG RESULT. THIS CAN LEAD TO AN INCORRECT RESULT BEING REPORTED FOR THE CMV AVIDITY ASSAY. RESULTS PROVIDED ON (B)(6) 2025: FEMALE PATIENT DOB: (B)(6)1989, SID (B)(6). FIRST RESULT, NO DILUTION: CMVAVI=27.6. RETEST CORRECT DILUTION: CMVAVI=89.0 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE AMS SOFTWARE. - IF THERE IS AN INSTRUMENT/ASSAY ISSUE DUE TO THE CMV IGG NOT BEING MEASURED CORRECTLY / ERROR MESSAGE: RE-PROCESSING OF TUBE WILL BEGIN TO RERUN THE CMV IGG. THE CMV AVIDITY TESTS CAN BE SENT TO THE ALINITY FOR TESTING BEFORE A CORRECT DILUTION CAN BE APPLIED RESULTING IN THE CMV AVIDITY TEST BEING MEASURED IN STRAIGHT DILUTION INSTEAD OF THE APPROPRIATE DILUTION BASED ON THE CMV IGG RESULT. THIS CAN LEAD TO AN INCORRECT RESULT BEING REPORTED FOR THE CMV AVIDITY ASSAY. RESULTS PROVIDED ON (B)(6) 2025: FEMALE PATIENT DOB: (B)(6) 1989 SID (B)(6). FIRST RESULT, NO DILUTION: CMVAVI=27.6, RETEST CORRECT DILUTION: CMVAVI=89.0, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE AMS SOFTWARE: IF THERE IS AN INSTRUMENT/ASSAY ISSUE DUE TO THE CMV IGG NOT BEING MEASURED CORRECTLY / ERROR MESSAGE: RE-PROCESSING OF TUBE WILL BEGIN TO RERUN THE CMV IGG THE CMV AVIDITY TESTS CAN BE SENT TO THE ALINITY FOR TESTING BEFORE A CORRECT DILUTION CAN BE APPLIED RESULTING IN THE CMV AVIDITY TEST BEING MEASURED IN STRAIGHT DILUTION INSTEAD OF THE APPROPRIATE DILUTION BASED ON THE CMV IGG RESULT. THIS CAN LEAD TO AN INCORRECT RESULT BEING REPORTED FOR THE CMV AVIDITY ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447955 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female