BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 25010222 · Received April 27, 2026

    Report

    Report Number
    3002809144-2026-00108
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 27, 2026
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C19 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C19, 510K K210596.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOXO IGG RESULTS GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 39-YEAR-OLD PREGNANT FEMALE PATIENT WHO IS BEING MONITORED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). 21FEB2026 RESULT = 0.2 IU/ML. 16MAR2026 RESULT = 0.5 IU/ML. 14APR2026 TOXO IGG RESULT = 5.1 IU/ML, TOXO IGM RESULT = 0.06 INDEX, REPEAT RESULTS ON (B)(6) 2026. TOXO IGG = 4.97 IU/ML AND 4.97 IU/ML, TOXO IGM = 0.06 INDEX AND 0.06 INDEX . THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272402 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 84084BE00 00380740009212

    Patients

    Seq Age Sex Outcome Treatment
    1