BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 25062487 · Received May 3, 2026

    Report

    Report Number
    3005094123-2026-00205
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/31, AND 510K/PMA/BLA OF 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 OBSERVED A POSITIVE ALINITY I TOTAL BHCG RESULT ON A PATIENT THAT REPEATED NEGATIVE. ON (B)(6) 2026, SID (B)(6), (FEMALE, 18 YEARS OLD) GENERATED ALINITY I TOTAL BHCG POSITIVE OF 136.58 MIU/ML, THAT REPEATED NEGATIVE OF 2.3 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428777 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81659UD00 00380740121518

    Patients

    Seq Age Sex Outcome Treatment
    1