BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-TPO REAGENT KIT

    MDR report key: 22081836 · Received May 23, 2025

    Report

    Report Number
    1415939-2025-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 2, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JZO
    UDI-DI
    00380740003487
    PMA / PMN Number
    K052407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K47-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K47-27, WITH 510K/PMA/BLA NUMBER K052407. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ARCHITECT ANTI-TPO AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, INDICATING ACCEPTABLE PRODUCT PERFORMANCE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-TPO REAGENT LOT 50484UN24 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT ANTI-TPO. THE CUSTOMER REPORTED THAT THIS IMPACTED BOTH QC AND PATIENT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING SAMPLE DATA FROM (B)(6) 2025: CUSTOMER NORMAL RANGE IS <5.61IU/ML SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 9.04 SAMPLE ID (B)(6) INITIAL RESULT WAS 4.9 AND REPEAT RESULT WAS 16.07 SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 5.95 SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 10.85. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT ANTI-TPO. THE CUSTOMER REPORTED THAT THIS IMPACTED BOTH QC AND PATIENT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING SAMPLE DATA FROM 15 MAY 2025: CUSTOMER NORMAL RANGE IS <5.61IU/ML. SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 9.04. SAMPLE ID (B)(6) INITIAL RESULT WAS 4.9 AND REPEAT RESULT WAS 16.07. SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 5.95. SAMPLE ID (B)(6) INITIAL RESULT WAS < 3.00 AND REPEAT RESULT WAS 10.85. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328206 ARCHITECT ANTI-TPO REAGENT KIT SYSTEM, TEST, THYROID AUTOANTIBODY JZO ABBOTT LABORATORIES 50484UN24 00380740003487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)