BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 24558155 · Received March 10, 2026

    Report

    Report Number
    3005094123-2026-00117
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 2, 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 FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K983424.

    Additional Manufacturer Narrative · 0

    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 80029UD01, HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LIST NUMBER, 07K78. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES 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 80029UD01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT GENERATED FOR A PATIENT SAMPLE WHO IS NOT PREGNANT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0-5 MIU/ML IS NEGATIVE):. INITIAL RESULT = 400 MIU/ML, MANUAL 2X DILUTION RESULT = <4.6 MIU/ML, REPEAT RESULT ON SNIBE LUMINESCENCE PLATFORM = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT GENERATED FOR A PATIENT SAMPLE WHO IS NOT PREGNANT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0-5 MIU/ML IS NEGATIVE): INITIAL RESULT = 400 MIU/ML, MANUAL 2X DILUTION RESULT = <4.6 MIU/ML, REPEAT RESULT ON SNIBE LUMINESCENCE PLATFORM = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309889 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 80029UD01 00380740163297

    Patients

    Seq Age Sex Outcome Treatment
    1