BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 23513646 · Received November 10, 2025

    Report

    Report Number
    3002809144-2025-00357
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740009205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION OF LOT: 71072BE00 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 FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW FOR THE LIST NUMBER DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE'S OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT: 71072BE00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL LOT PERFORMANCE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOXO IGG REAGENT LOT: 71072BE00 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C19-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C19, WITH 510K/PMA/BLA NUMBER K210596.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT TOXO IGG RESULT GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025, SID: (B)(6): TOXO IGG RESULT = 5.5 IU/ML (REACTIVE); REPEAT RESULT = 0.2 IU/ML (NONREACTIVE). THIS PATIENT SAMPLE WAS INITIALLY HEMOLYZED AND THE REPEAT RESULT WAS TESTED ON A NEW SAMPLE TAKEN FROM THE PATIENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT TOXO IGG RESULT GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025, SID (B)(6): TOXO IGG RESULT = 5.5 IU/ML (REACTIVE); REPEAT RESULT = 0.2 IU/ML (NONREACTIVE). THIS PATIENT SAMPLE WAS INITIALLY HEMOLYZED AND THE REPEAT RESULT WAS TESTED ON A NEW SAMPLE TAKEN FROM THE PATIENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311549 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 71072BE00 00380740009205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, I1SR54786.| ARC I1000SR MOD, 01L86-01, I1SR54786.