BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23423337 · Received October 30, 2025

    Report

    Report Number
    3005094123-2025-00546
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 8, 2026
    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

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT TOTAL B-HCG REAGENT, LOT 71453UD01. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. 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 OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT TOTAL B-HCG REAGENT, LOT 71453UD01.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78-74 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (= 5.00 MIU/ML IS NEGATIVE, 5.00 TO 25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): SID (B)(6). INITIAL ARCHITECT TOTAL -HCG RESULT = 651.04 MIU/ML (POSITIVE). REPEAT RESULT = 1.2 MIU/ML (NEGATIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (= 5.00 MIU/ML IS NEGATIVE, >5.00 TO <25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): SID (B)(6): INITIAL ARCHITECT TOTAL -HCG RESULT = 651.04 MIU/ML (POSITIVE) REPEAT RESULT = <1.2 MIU/ML (NEGATIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617992 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 71453UD01 00380740163280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)