BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23425687 · Received October 30, 2025

    Report

    Report Number
    3005094123-2025-00549
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 22, 2025
    Report Date
    December 17, 2025
    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

    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/PMA/BLA NUMBER K983424. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LIST NUMBER ARCHITECT TOTAL -HCG REAGENT. FURTHERMORE, IN HOUSE ACCURACY TESTING OF THE COMPLAINT LOT WAS CONDUCTED WHICH CONCLUDED THE COMPLAINT LOT MET ACCEPTANCE CRITERIA, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL -HCG REAGENT, LOT 71474UD02 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG FOR A 36-YEAR-OLD FEMALE UNDERGOING EMBRYO TRANSFER. THE FOLLOWING RESULTS WERE PROVIDED: B-HCG REFERENCE RANGE: <5.0 MIU/ML, NOT PREGNANT. (B)(6) 2025, B-HCG RESULT (AFTER EMBRYO TRANSFER) = <1.20 MIU/ML; (B)(6) 2025, B-HCG RESULT= 9589.40 MIU/ML. THE PHYSICIAN QUESTIONED THE RESULT SINCE IT WAS TOO SOON FOR THE RESULT TO BE HIGH. THE SAMPLE WAS TESTED WITH COLLOIDAL GOLD METHOD, RESULT= NEGATIVE. THE PATIENT WAS REDRAWN AND THE B-HCG RESULT= <1.20 MIU/ML. ADDITIONAL RESULTS WERE PROVIDED: PROGESTERONE REFERENCE RANGE: 0-0.3 NG/ML IN THE FOLLICULAR PHASE, 1.2-15.9 NG/ML IN THE OVULATORY PHASE, 1.2-15.9 NG/ML IN THE LUTEAL PHASE, 0-0.2 NG/ML AFTER MENOPAUSE. (B)(6) 2026, PROGESTERONE RESULT= 7.32 NG/ML; (B)(6) 2025, PROGESTERONE RESULT= 7.61 NG/ML; (B)(6) 2025, PROGESTERONE RESULT= 7.98 NG/ML; (B)(6) 2025, PROGESTERONE RESULT <0.10 NG/ML. 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 UNDERGOING EMBRYO TRANSFER. THE FOLLOWING RESULTS WERE PROVIDED: B-HCG REFERENCE RANGE: <5.0 MIU/ML, NOT PREGNANT (B)(6) 2025, B-HCG RESULT (AFTER EMBRYO TRANSFER) = <1.20 MIU/ML; (B)(6) 2025, B-HCG RESULT= 9589.40 MIU/ML. THE PHYSICIAN QUESTIONED THE RESULT SINCE IT WAS TOO SOON FOR THE RESULT TO BE HIGH. THE SAMPLE WAS TESTED WITH COLLOIDAL GOLD METHOD, RESULT= NEGATIVE. THE PATIENT WAS REDRAWN AND THE B-HCG RESULT= <1.20 MIU/ML. ADDITIONAL RESULTS WERE PROVIDED: PROGESTERONE REFERENCE RANGE: 0-0.3 NG/ML IN THE FOLLICULAR PHASE, 1.2-15.9 NG/ML IN THE OVULATORY PHASE, 1.2-15.9 NG/ML IN THE LUTEAL PHASE, 0-0.2 NG/ML AFTER MENOPAUSE. (B)(6) 2026, PROGESTERONE RESULT= 7.32 NG/ML; (B)(6) 2025, PROGESTERONE RESULT= 7.61 NG/ML; (B)(6) 2025, PROGESTERONE RESULT= 7.98 NG/ML; (B)(6) 2025, PROGESTERONE RESULT <0.10 NG/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298153 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 71474UD02 00380740163297

    Patients

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