BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP REAGENT KIT

    MDR report key: 24814748 · Received April 8, 2026

    Report

    Report Number
    3002809144-2026-00087
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740169954
    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 A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08D06, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, WITH 510K/PMA/BLA NUMBER 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 OBSERVED FALSE NONREACTIVE ARCHITECT SYPHILIS RESULTS FOR ONE 54-YEAR-OLD MALE PATIENT DIAGNOSED WITH SYNCOPE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): ARCHITECT SYPHILIS WAS 0.44 S/CO (NONREACTIVE), DOMESTIC PLATFORM POSITIVE, TPPA WEAKLY POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880556 ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 83314BE02 00380740169954

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male ARC I2000SR INST, 03M74-02, (B)(6)