BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 25221834 · Received May 19, 2026

    Report

    Report Number
    3002809144-2026-00126
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 07P60-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P60-21/31, AND 510K/PMA/BLA OF K153730.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I SYPHILIS TP RESULTS FOR A 35-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID: (B)(6) INITIAL RESULT WAS 0.11, REPEAT RESULT WAS 0.12 S/CO. THE SAMPLE WAS TESTED WITH ELISA, AND THE RESULTS WERE 7.422 AND 7.656, WHICH ARE POSITIVE. THE TPPA WAS WEAKLY POSITIVE. THE RPR WAS NEGATIVE AND RESULT WITH THE MINDRAY ASSAY WAS 0.05, WHICH IS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487668 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81272BE01 00380740161927

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).