BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 24607646 · Received March 16, 2026

    Report

    Report Number
    3002809144-2026-00062
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8D06-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, WITH 510K/PMA/BLA NUMBER K153730. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE RESULT WAS INCONSISTENT WITH THE RESULTS FROM OTHER METHODS. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): ARCHITECT SYPHILIS TP RESULT = 0.23 S/CO (NONREACTIVE); AUTOBIO LUMINESCENCE PLATFORM RESULT = 2.65 S/CO (POSITIVE); TPPA RESULT = POSITIVE; COLLOIDAL GOLD RESULT = POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21213 ARCHITECT SYPHILIS TP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 76480BE01 00380740161910

    Patients

    Seq Age Sex Outcome Treatment
    1