BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP REAGENT KIT

    MDR report key: 25060298 · Received May 1, 2026

    Report

    Report Number
    3002809144-2026-00115
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 1, 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

    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 8D06-87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-41, 510K K153730. ALL AVAILABLE PATIENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT SYPHILIS RESULT GENERATED ON ARCHITECT I2000SR ANALYZER FOR A 60-YEAR-OLD MALE PATIENT (SID (B)(6)). THE ARCHITECT RESULTS WERE 0.47 S/CO AND 0.46 S/CO (NEGATIVE). AUTOBIO RESULT WAS 11.35 (POSITIVE). TPPA WAS POSITIVE. MINDRAY WAS 1.07 (POSITIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117416 ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81352BE01 00380740169961

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male ARC I2000SR INST, 03M74-02, (B)(6).