BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 25019594 · Received April 28, 2026

    Report

    Report Number
    3005094123-2026-00198
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 07P20 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED POSITIVE ALINITY I TOTAL BHCG RESULTS. ON (B)(6) 2026, SID: (B)(6) (FEMALE, 19-YEAR-OLD) GENERATED POSITIVE BHCG OF 41.0 MIU/ML RESULTS THAT WERE QUESTIONED. THE SAMPLE WAS REPEATED BHCG NEGATIVE <2.3 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626483 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 83405UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1