BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP REAGENT KIT

    MDR report key: 25220776 · Received May 19, 2026

    Report

    Report Number
    3002809144-2026-00130
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 19, 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08D06-87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, WITH 510K NUMBER K153730.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT SYPHILIS RESULT GENERATED ON AN ARCHITECT I2000 PROCESSING MODULE FOR A 69-YEAR-OLD MALE PATIENT WHO HAD A HISTORY OF POSITIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6); CURRENT RESULT = 0.64 S/CO & 0.75 S/CO, HISTORICAL RESULTS WERE 1.12 S/CO (IN 2023) & 1.02 S/CO (IN 2024). THE CUSTOMER REFERENCE RANGE: (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214148 ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81352BE01 00380740169961

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male ARC I2000SR INST, 03M74-02, (B)(6).