BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 22293975 · Received June 19, 2025

    Report

    Report Number
    3005094123-2025-00312
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 12, 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

    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.

    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 ACCURACY TESTING WITH A RETAINED REAGENT KIT.. 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 A SLIGHT INCREASE IN COMPLAINT ACTIVITY FOR LOT 65706UD01, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR ARCHITECT TOTAL B-HCG REAGENT REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT TOTAL B-HCG REAGENT, LOT 65706UD01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG GENERATED FROM ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE INITIAL RESULT WAS 14,073.08 MIU/ML, THE RETEST RESULT WAS < 1.20 MIU/ML. PER THE CUSTOMER THE DISCREPANT RESULT WAS NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG GENERATED FROM ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE INITIAL RESULT WAS 14,073.08 MIU/ML, THE RETEST RESULT WAS < 1.20 MIU/ML PER THE CUSTOMER THE DISCREPANT RESULT WAS NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863946 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 65706UD01 00380740163280

    Patients

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