BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 22675241 · Received July 31, 2025

    Report

    Report Number
    3002809144-2025-00249
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 12, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740009205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 06C19 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C19, WITH 510K NUMBER K210596. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT TOXO IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. THE OVERALL PERFORMANCE OF ARCHITECT TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT(S) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. REVIEW OF APPLICABLE FIELD DATA SUGGESTS THAT THE PERFORMANCE IS ACCEPTABLE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOXO IGG REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT TOXO IGG RESULTS FOR A PREGNANT FEMALE PATIENT WITH A HISTORY OF NONREACTIVE TOXO IGG RESULTS. THE FOLLOWING DATA WAS PROVIDED (>/= TO 3.0 IU/ML IS REACTIVE): (B)(6) 2025 SID (B)(6) INITIAL RESULT 4.2 IU/ML, REPEATED ON (B)(6) 2025 3.5 IU/ML. THE SAME SAMPLE HAS BEEN ANALYZED WITH A DIFFERENT METHOD (CHEMILUMINESCENCE) AND THE RESULT WAS NONREACTIVE. TOXO IGM ANALYZED ON (B)(6) 2025 AND THE RESULT WAS 0.09 INDEX (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333144 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 71072BE00 00380740009205

    Patients

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