BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-TPO REAGENT KIT

    MDR report key: 23067481 · Received September 16, 2025

    Report

    Report Number
    3008344661-2025-00130
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JZO
    UDI-DI
    00380740150617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 09P35-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 9P35-21, WITH 510K/PMA/BLA NUMBER K052407.

    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, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-TPO ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71694FZ00. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 71694FZ00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. IN-HOUSE ACCURACY TESTING OF A RETAINED REAGENT KIT OF THE LOT 71694FZ00 WAS PERFORMED. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-TPO REAGENT LOT 71694FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I ANTI-TPO FOR TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: PATIENT 1, INITIAL ANTI-TPO RESULT= 1.45 IU/ML; REPEAT RESULT ON ANOTHER ALINITY= 7.77 IU/ML; REPEAT RESULT AFTER RECALIBRATION= 8.23 IU/ML. PATIENT 2, INITIAL ANTI-TPO RESULT= 3.46 IU/ML; REPEAT RESULT ON ANOTHER ALINITY= 7.76 IU/ML; REPEAT RESULT AFTER RECALIBRATION= 5.17 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I ANTI-TPO FOR TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: PATIENT 1, INITIAL ANTI-TPO RESULT= 1.45 IU/ML; REPEAT RESULT ON ANOTHER ALINITY= 7.77 IU/ML; REPEAT RESULT AFTER RECALIBRATION= 8.23 IU/ML PATIENT 2, INITIAL ANTI-TPO RESULT= 3.46 IU/ML; REPEAT RESULT ON ANOTHER ALINITY= 7.76 IU/ML; REPEAT RESULT AFTER RECALIBRATION= 5.17 IU/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681106 ALINITY I ANTI-TPO REAGENT KIT SYSTEM, TEST, THYROID AUTOANTIBODY JZO ABBOTT IRELAND DIAGNOSTICS DIVISION 71694FZ00 00380740150617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)