BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 25257275 · Received May 22, 2026

    Report

    Report Number
    3002809144-2026-00136
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740162009
    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 07P60-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P60-21 / 31, WITH 510K NUMBER K153730.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I SYPHILIS TP RESULT GENERATED FOR A MALE PATIENT SAMPLE THAT DID NOT MATCH THE PATIENT¿S HISTORICAL RESULTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <1 S/CO): INITIAL RESULT = 0.89 S/CO ROCHE RESULT = POSITIVE, TPPA RESULT = POSITIVE, HISTORICAL RESULT = POSITIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546147 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81332BE01 00380740162009

    Patients

    Seq Age Sex Outcome Treatment
    1