BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 25319222 · Received May 28, 2026

    Report

    Report Number
    3005094123-2026-00255
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 20, 2026
    Report Date
    May 28, 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 FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1 (42 YEAR OLD FEMALE): INITIAL RESULT = 37.89 IU/L, REPEAT = SAME RESULT. A NEW SAMPLE WAS COLLECTED WHICH GENERATED A NEGATIVE RESULT OF <1.2 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161010 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 80029UD01 00380740163297

    Patients

    Seq Age Sex Outcome Treatment
    1