BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-TPO REAGENT KIT

    MDR report key: 21621815 · Received March 17, 2025

    Report

    Report Number
    3008344661-2025-00031
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    September 25, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JZO
    UDI-DI
    00380740150617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE 1, SAMPLE 2, SAMPLE 3, SAMPLE 4, SAMPLE 5, SAMPLE 6. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 09P35-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 09P35-21, AND A 510K NUMBER OF K052407.

    Additional Manufacturer Narrative · 0

    FIELD 2A - D2A - COMMON DEVICE NAME UPDATED TO INCLUDE SYSTEM, TEST, THYROID AUTOANTIBODY IN THAT FIELD. THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ALINITY I ANTI-TPO RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND TESTING OF THE COMPLAINT LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. DEVICE HISTORY RECORD REVIEW ON LOT NUMBER 59185FZ00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT 59185FZ00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I ANTI-TPO, LOT NUMBER 59185FZ00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I ANTI-TPO RESULTS FOR SEVERAL PATIENTS WHEN COMPARING RESULTS TO A ROCHE ASSAY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR ALINITY ASSAY IS <5.61 IU/ML, FOR ROCHE IS <16.0 IU/ML): SAMPLE 1 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 62.9 IU/ML. SAMPLE 2 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 18.8 IU/ML. SAMPLE 3 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 19.5 IU/ML. SAMPLE 4 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.0 IU/ML. SAMPLE 5 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.1 IU/ML. SAMPLE 6 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.9 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I ANTI-TPO RESULTS FOR SEVERAL PATIENTS WHEN COMPARING RESULTS TO A ROCHE ASSAY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR ALINITY ASSAY IS <5.61 IU/ML, FOR ROCHE IS <16.0 IU/ML): SAMPLE 1 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 62.9 IU/ML. SAMPLE 2 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 18.8 IU/ML. SAMPLE 3 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 19.5 IU/ML. SAMPLE 4 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.0 IU/ML. SAMPLE 5 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.1 IU/ML. SAMPLE 6 INITIAL RESULT, ON (B)(6) 2024, WAS <3.00, REPEAT RESULT USING A ROCHE ASSAY WAS 21.9 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17627 ALINITY I ANTI-TPO REAGENT KIT SYSTEM, TEST, THYROID AUTOANTIBODY JZO ABBOTT IRELAND DIAGNOSTICS DIVISION 59185FZ00 00380740150617

    Patients

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