BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24775445 · Received April 3, 2026

    Report

    Report Number
    3005094123-2026-00159
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 21, 2026
    Report Date
    April 3, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163303
    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 07K78-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K78, WITH 510K NUMBER K983424.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG ON A PATIENT, THAT WAS REPORTED TO MEDICAL PROVIDER AND PROVIDED THE FOLLOWING DATA: SID (B)(6), 52 YEARS OLD FEMALE, INITIAL RESULT = 900 MIU/ML, REPEAT RESULTS =20 MIU/ML COLLOIDAL GOLD METHOD = WEAK POSITIVE . THE CUSTOMER REFERENCE RANGE; >10MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21660 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 76393UD03 00380740163303

    Patients

    Seq Age Sex Outcome Treatment
    1