BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 23057740 · Received September 15, 2025

    Report

    Report Number
    3002809144-2025-00295
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 24, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161910
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08D06-74, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 08D06-31, AND A 510K NUMBER OF K153730.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIST NUMBER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIST NUMBER AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIST NUMBER WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT SYPHILIS TP, LIST NUMBER 08D06, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS FOR ONE PATIENT. THE CUSTOMER STATED THE RESULT WAS NONREACTIVE WITH POSITIVE TPPA AND TRUST RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS FOR ONE PATIENT. THE CUSTOMER STATED THE RESULT WAS NONREACTIVE WITH POSITIVE TPPA AND TRUST RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759601 ARCHITECT SYPHILIS TP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 00380740161910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, ISR61634