BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP REAGENT KIT

    MDR report key: 24866157 · Received April 13, 2026

    Report

    Report Number
    3002809144-2026-00092
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740169961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) HOSPITAL. SECTION E1 ADDRESS 2: MAXIMUM CHARACTER LIMIT WAS REACHED, THE FULL ADDRESS IS INNER MONGOLIA AUTONOMOUS REGION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8D06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, AND 510K/PMA/BLA OF K153730. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 54-YEAR-OLD FEMALE PATIENT, WHICH WERE INCONSISTENT WITH THE PATIENT¿S PREVIOUS RESULT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): SID (B)(4): ARCHITECT SYPHILIS TP RESULT = 0.89 S/CO (NONREACTIVE), 0.86 S/CO (NONREACTIVE). PREVIOUS RESULT (B)(6) 2025: ARCHITECT SYPHILIS TP RESULT = 1.15 S/CO (REACTIVE) COLLOIDAL GOLD RESULT = POSITIVE TPPA RESULT = WEAK POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915392 ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81352BE01 00380740169961

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ARC I2000SR INST, 03M74-02, ISR60776