BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24524378 · Received March 5, 2026

    Report

    Report Number
    3005094123-2026-00107
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 30, 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

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K78 , WITH 510K/PMA/BLA NUMBER K983424. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA FOR A 32-YEAR-OLD FEMALE PATIENT (SAMPLE ID (B)(6): THE INITIAL HCG LEVEL WAS 3,233.2 MIU/ML (POSITIVE), WHICH WAS CONSIDERED CLINICALLY INCONSISTENT. WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS <1.2 MIU/ML (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582806 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 80539UD01 00380740163280

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ARC I2000SR INST, 03M74-02, (B)(6)