BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23542601 · Received November 13, 2025

    Report

    Report Number
    3005094123-2025-00572
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 12, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740014964
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION 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 FIELD DATA OF ARCHITECT TOTAL B-HCG REAGENT, LOT 73561UD00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT TOTAL B-HCG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73561UD00. THE OVERALL PERFORMANCE OF ARCHITECT TOTAL B-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE REVIEW DETERMINED THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL B-HCG REAGENT, LOT 73561UD00.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6) 32YRS OLD FEMALE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 NEGATIVE RESULT ON THE ARCHITECT B-HCG ASSAY FOR A 32YRS OLD FEMALE PATIENT UNDERGOING IVF TREATMENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=< 1.20 MIU/ML (NEGATIVE=< OR=5.00 MIU/ML) /RAPID PREGNANCY TEST=POSITIVE. REDRAWN AND REPEATED ON (B)(6) 2025 SID (B)(6)= >15000 MIU/ML (POSITIVE= > OR =25.00 MIU/ML) /REPEATED= >15000 MIU/ML. ON (B)(6) 2025 AUTO DILUTION 1:15 FROM (B)(6) 2025 SPECIMEN SID (B)(6) =20525.96 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE ARCHITECT B-HCG ASSAY FOR A 32YRS OLD FEMALE PATIENT UNDERGOING IVF TREATMENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=< 1.20 MIU/ML (NEGATIVE=< OR=5.00 MIU/ML) /RAPID PREGNANCY TEST=POSITIVE REDRAWN AND REPEATED ON (B)(6) 2025 SID (B)(6) = >15000 MIU/ML (POSITIVE= > OR =25.00 MIU/ML) /REPEATED= >15000 MIU/ML. ON (B)(6) 2025 AUTO DILUTION 1:15 FROM (B)(6) 2025 SPECIMEN SID (B)(6) =20525.96 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882979 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 73561UD00 00380740014964

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ARC I2K PROC MOD, 03M74-01, (B)(6)