BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 22293245 · Received June 19, 2025

    Report

    Report Number
    3005094123-2025-00310
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 26, 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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K78-74THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K78, WITH 510K NUMBER K983424.

    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 OF A RETAINED REAGENT KIT LOT 67166UD02. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 67166UD02, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07K78. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOTAL B-HCG REAGENT LOT 67166UD02 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE INITIAL ARCHITECT TOTAL B-HCG RESULT WAS >2000 MIU/ML, RETEST WAS NEGATIVE. THE TEST STRIP RESULT WAS ALSO NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE INITIAL ARCHITECT TOTAL B-HCG RESULT WAS >2000 MIU/ML, RETEST WAS NEGATIVE. THE TEST STRIP RESULT WAS ALSO NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724526 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 67166UD02 00380740163280

    Patients

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