BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 24745024 · Received March 31, 2026

    Report

    Report Number
    3002809144-2026-00077
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 23, 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 08D06-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08D06-41, 510K 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 PREGNANT FEMALE WITH A HISTORY OF SYPHILIS. THE INITIAL RESULT = 0.56 S/CO, REPEAT RESULTS WERE CONSISTENT. COLLOIDAL GOLD RESULT WAS POSITIVE. THE CUSTOMER USED THE YHLO PLATFORM FOR TESTING WHICH GENERATED A RESULT = 1.2 S/CO (POSITIVE). THE FIRST TIME THIS WOMAN WAS PREGNANT, SHE RECEIVED A CONFIRMED DIAGNOSIS OF SYPHILIS AND UNDERWENT TREATMENT. NOW, IN HER SECOND PREGNANCY, SHE HAS A FALSE NEGATIVE RESULT ON THE ARCHITECT WHILE THE COLLOIDAL GOLD METHOD IS POSITIVE. WHEN USING THE ABBOTT TREPONEMA PALLIDUM ANTIBODY LATEX AGGLUTINATION TEST, THE RESULT WAS POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807714 ARCHITECT SYPHILIS TP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81352BE01 00380740169961

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female ARC I2K PROC MOD, 03M74-01,(B)(6)