BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23604816 · Received November 20, 2025

    Report

    Report Number
    3005094123-2025-00587
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 16, 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K78, WITH 510K NUMBER K983424.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07K78-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 7K78, WITH 510K NUMBER: K983424. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT: 71474UD02, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LIST NUMBER: 07K78. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCE'S, POTENTIAL NONCONFORMANCE'S OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOTAL B-HCG REAGENT LOT: 71474UD02 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR ONE 37-YEAR-OLD FEMALE PATIENT WITH AN INITIAL DIAGNOSIS OF IRREGULAR MENSTRUATION. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL ARCHITECT TOTAL B-HCG RESULT WAS 3759.45 MIU/ML. THE SAMPLE WAS RETESTED, AND THE RESULT WAS <1.20 MIU/ML. A RETEST USING COLLOIDAL GOLD SHOWED A NEGATIVE RESULT FOR BHCG. OTHER RESULTS PROVIDED: PROG RESULT 4.54 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR ONE 37-YEAR-OLD FEMALE PATIENT WITH AN INITIAL DIAGNOSIS OF IRREGULAR MENSTRUATION. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6) INITIAL ARCHITECT TOTAL B-HCG RESULT WAS 3759.45 MIU/ML. THE SAMPLE WAS RETESTED, AND THE RESULT WAS <1.20 MIU/ML. A RETEST USING COLLOIDAL GOLD SHOWED A NEGATIVE RESULT FOR BHCG. OTHER RESULTS PROVIDED: PROG RESULT 4.54 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661415 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 71474UD02 00380740163297

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female ARC I2000SR INST, 03M74-02,(B)(6)