BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 23423184 · Received October 30, 2025

    Report

    Report Number
    3002809144-2025-00339
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740009212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C19-35 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C19, WITH 510K/PMA/BLA NUMBER K210596. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT 76588BE00 PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT TOXO IGG ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCE OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL CONTROLS AND THE P35 PANEL MET SPECIFICATIONS AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT PERFORMS AS EXPECTED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT TOXO IGG REAGENT, LOT NUMBER 76588BE00.

    Description of Event or Problem · 0

    ON HOLD FOR R.T 10.30 THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TOXO IGG RESULT FOR A 28-YEAR-OLD PREGNANT FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: > OR = TO 3.0 IU/ML IS REACTIVE): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.8 IU/ML. ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.12 IU/ML. A NEW SAMPLE WAS COLLECTED: ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 11.50 IU/ML. ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.10 IU/ML. THE INITIAL SAMPLE (B)(6) WAS REPEATED ON A DIFFERENT INSTRUMENT = 11.10 IU/ML. ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.10 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TOXO IGG RESULT FOR A 28-YEAR-OLD PREGNANT FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: > OR = TO 3.0 IU/ML IS REACTIVE): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.8 IU/ML. ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.12 IU/ML. A NEW SAMPLE WAS COLLECTED: ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 11.50 IU/ML, ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.10 IU/ML, THE INITIAL SAMPLE (SID (B)(6) WAS REPEATED ON A DIFFERENT INSTRUMENT = 11.10 IU/ML, ADDITIONAL LABORATORY DATA WAS PROVIDED: TOXO IGM = 0.10 IU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250795 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 76588BE00 00380740009212

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female ARC I2000SR INST, 03M74-02, (B)(6).