BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 25254055 · Received May 22, 2026

    Report

    Report Number
    3005094123-2026-00240
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163327
    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 7P51-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/-31, WITH 510K/PMA/BLA NUMBER K170317.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR B-HCG: </ = 5.0 MIU/ML IS NEGATIVE): INITIAL B-HCG RESULT = 241.7 MIU/ML REPEAT B-HCG RESULT = 189.47 MIU/ML. SECOND REPEAT B-HCG RESULT = < 2.3 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263454 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81525UD01 00380740163327

    Patients

    Seq Age Sex Outcome Treatment
    1