BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24733178 · Received March 30, 2026

    Report

    Report Number
    3005094123-2026-00147
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 22, 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

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 7K78-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 7K78, 510K K983424. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID: (B)(6) INITIAL RESULT WAS 290.78 MIU/ML (POSITIVE) AND WHEN THE SAMPLE WAS REPEATED THE RESULT WAS < 1.20 MIU/ML (NEGATIVE). COLLOIDAL GOLD GENERATED A NEGATIVE RESULT. PATIENT INFORMATION: 44 YEAR OLD FEMALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83757 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81662UD03 00380740163303

    Patients

    Seq Age Sex Outcome Treatment
    1