BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24621580 · Received March 17, 2026

    Report

    Report Number
    3005094123-2026-00132
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163280
    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 FOLLOW-UP 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 07K78-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K78, WITH 510K/PMA/BLA NUMBER K983424.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6): THE INITIAL HCG LEVEL WAS 53 MIU/ML (POSITIVE), AND WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS NEGATIVE (RESULT NOT PROVIDED). THE CUSTOMER REPORTED THAT THERE WERE MULTIPLE RETEST RESULTS THAT WERE ALL NEGATIVE (RESULTS AND PLATFORM NOT PROVIDED). THE CUSTOMER REPORTED THAT THE PATIENT IS NOT PREGNANT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408338 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 80539UD01 00380740163280

    Patients

    Seq Age Sex Outcome Treatment
    1