BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 22047102 · Received May 19, 2025

    Report

    Report Number
    3002809144-2025-00160
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 15, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740211233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 6C19-36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C19, AND 510K/PMA/BLA OF K210596. SECTION A1 PATIENT IDENTIFIER OF MULTIPLE IS SAMPLE IDS (B)(6). SECTION A3B GENDER NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOWUP 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 FIELD DATA REVIEW. 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. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES 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 66437BE00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. 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 66437BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT TOXO IGG RESULT. DATA PROVIDED. 1ST TEST: (B)(6) 2024 (0 MONTHS AFTER BIRTH) 1.7 IU/ML GRAYZONE. 2ND TEST: (B)(6) 2025 (2 MONTHS AFTER BIRTH) < 1.6 IU/ML NEGATIVE. 3RD TEST: (B)(6) 2025 (5 MONTHS AFTER BIRTH) 3.7 IU/ML (USING ID (B)(6)), RETEST: 4.3 IU/ML (USING SID (B)(6)) REACTIVE. TOXO IGM NEGATIVE AT 0.11 IU/ML NO IMPACT PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT TOXO IGG RESULT. DATA PROVIDED. 1ST TEST: (B)(6) 2024 (0 MONTHS AFTER BIRTH) 1.7 IU/ML GRAYZONE 2ND TEST: (B)(6) 2025 (2 MONTHS AFTER BIRTH) < 1.6 IU/ML NEGATIVE 3RD TEST: (B)(6) 2025 (5 MONTHS AFTER BIRTH) 3.7 IU/ML (USING ID (B)(6), RETEST: 4.3 IU/ML (USING SID (B)(6) REACTIVE. TOXO IGM NEGATIVE AT 0.11 IU/ML NO IMPACT PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139413 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 66437BE00 00380740211233

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Male ARC I2K PROC MOD, 03M74-01, (B)(6)| ARC I2K PROC MOD, 03M74-01, (B)(6)