BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 24865651 · Received April 13, 2026

    Report

    Report Number
    3002809144-2026-00091
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 22, 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. 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. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I SYPHILIS RESULT GENERATED FOR A PATIENT WHEN PROCESSED ON AN ALINITY I PROCESSING MODULE WHO DOESN¿T HAVE CLINICAL SYMPTOMS ASSOCIATED WITH SYPHILIS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6), INITIAL RESULT =0.24 S/CO, REPEAT RESULTS (ELISA)= 2.42 S/CO, TPAA = STRONG POSITIVE. REPEAT RESULTS ON THIS ANALYZER =0.23 S/CO & SYSMEX =0.19 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106347 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 81272BE01 00380740161927

    Patients

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