BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23369864 · Received October 23, 2025

    Report

    Report Number
    3005094123-2025-00532
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 5, 2025
    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 THE SAME PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K78, WITH 510K/PMA/BLA NUMBER K983424. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 71453UD01; HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE ARCHITECT TOTAL -HCG ASSAY (LIST NUMBER 07K78). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 71453UD01 AND THE COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. IN THIS CASE, THE INITIAL FALSE ELEVATED RESULT IS LIKELY DUE TO A SAMPLE INTEGRITY ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT TOTAL -HCG REAGENT, LOT NUMBER 71453UD01, WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG FOR A 36-YEAR-OLD FEMALE CLINICALLY DIAGNOSED WITH IRREGULAR MENSTRUATION. WHEN THE SAMPLE WAS REPEATED ON THE BECKMAN PLATFORM THE RESULT WAS NEGATIVE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF 0-5 IU/L): INITIAL B-HCG RESULT= 160.06 IU/L; REPEAT RESULT AFTER RECENTRIFUGATION= 159 IU/L; REPEAT RESULT (BECKMAN PLATFORM)= NEGATIVE. ADDITIONAL LAB RESULTS PROVIDED: PROGESTERONE= 0.3 NMOL/L; RF AND CCP= POSITIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG FOR A 36-YEAR-OLD FEMALE CLINICALLY DIAGNOSED WITH IRREGULAR MENSTRUATION. WHEN THE SAMPLE WAS REPEATED ON THE BECKMAN PLATFORM THE RESULT WAS NEGATIVE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF 0-5 IU/L): INITIAL B-HCG RESULT= 160.06 IU/L; REPEAT RESULT AFTER RECENTRIFUGATION= 159 IU/L; REPEAT RESULT (BECKMAN PLATFORM) = NEGATIVE. ADDITIONAL LAB RESULTS PROVIDED: PROGESTERONE= 0.3 NMOL/L; RF AND CCP= POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544905 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 71453UD01 00380740163280

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female ARC I2000SR INST, 03M74-02, (B)(6)