BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24248296 · Received February 3, 2026

    Report

    Report Number
    3005094123-2026-00051
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 24, 2026
    Report Date
    March 24, 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

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K78 THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, AND 510K OF 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.

    Additional Manufacturer Narrative · 0

    SECTION B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 11MAR2026. THE CUSTOMER BELIEVES THE ARCHITECT TOTAL BHCG NEGATIVE RESULTS IS CORRECT AND THE URINE STRIP POSITIVE RESULT IS INCORRECT FOR THE PATIENT. THE CUSTOMER ALSO BELIEVES THE ARCHITECT TOTAL BHCG REAGENT AND ARCHITECT INSTRUMENT ARE WORKING WITH NO ISSUES. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER GENERATED A NEGATIVE ARCHITECT TOTAL BHCG RESULT. THE PATIENT (26 YEAR OLD FEMALE) GENERATED ARCHITECT TOTAL BHCG NEGATIVE RESULT OF <1.2 MIU/ML, REPEATED NEGATIVE OF <1.2 MIU/ML (REFERENCE RANGE: <5MIU/ML). THE PATIENT SUSPECTED A PREGNANCY, AND USED A URINE TEST STRIP WITH A MORNING SAMPLE WITH A POSITIVE RESULT . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER GENERATED A NEGATIVE ARCHITECT TOTAL BHCG RESULT. THE PATIENT (26 YEAR OLD FEMALE) GENERATED ARCHITECT TOTAL BHCG NEGATIVE RESULT OF <1.2 MIU/ML, REPEATED NEGATIVE OF <1.2 MIU/ML (REFERENCE RANGE: <5MIU/ML). THE PATIENT SUSPECTED A PREGNANCY, AND USED A URINE TEST STRIP WITH A MORNING SAMPLE WITH A POSITIVE RESULT . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON 11MAR2026. THE CUSTOMER BELIEVES THE ARCHITECT TOTAL BHCG NEGATIVE RESULTS IS CORRECT AND THE URINE STRIP POSITIVE RESULT IS INCORRECT FOR THE PATIENT. THE CUSTOMER ALSO BELIEVES THE ARCHITECT TOTAL BHCG REAGENT AND ARCHITECT INSTRUMENT ARE WORKING WITH NO ISSUES. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306585 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 80029UD02 00380740163303

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female ARC I2000SR INST, 03M74-02, ISR61592.| ARC I2000SR INST, 03M74-02, ISR61592.