BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 25260167 · Received May 22, 2026

    Report

    Report Number
    3005094123-2026-00247
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 07P51-30, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31, WITH 510K/PMA/BLA NUMBER K170317. 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 REPORTED A FALSE POSITIVE ALINITY I TOTAL -HCG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 38-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED, AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): INITIAL RESULT ((B)(6)) = 60 IU/L (POSITIVE). REPEAT RESULT ((B)(6)) = <3 IU/L, <3 IU/L, <3 IU/L (ALL NEGATIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551504 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 84201UD00 00380740121518

    Patients

    Seq Age Sex Outcome Treatment
    1