BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 25201886 · Received May 18, 2026

    Report

    Report Number
    3005094123-2026-00228
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K983424.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL HCG RESULT GENERATED FOR A 29-YEAR-OLD FEMALE PATIENT SAMPLE WITH ABNORMAL UTERINE BLEEDING. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE <5 MIU/ML IS NEGATIVE): SAMPLE ID: (B)(6) INITIAL RESULT = 26.61 MIU/ML, REPEAT RESULTS = <1.2 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254360 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81662UD02 00380740163297

    Patients

    Seq Age Sex Outcome Treatment
    1