BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 21807319 · Received April 9, 2025

    Report

    Report Number
    3005094123-2025-00158
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    April 5, 2025
    Report Date
    May 15, 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

    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 KIT OF THE COMPLAINT LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. 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 LIST NUMBER 7K78. ADDITIONALLY, ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, INDICATING THAT THE LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT TOTAL B-HCG REAGENT LOT 65706UD01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K78-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K78, WITH 510K/PMA/BLA NUMBER K983424.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: NON-PREGNANT WOMEN < 5 MIU/ML): PATIENT ID #2: INITIAL B-HCG RESULT = 30.19 MIU/ML; REPEAT RESULT = < 1.20 MIU/ML. THE COLLOIDAL GOLD METHOD WAS USED, AND THE RESULT OBTAINED WAS NEGATIVE. THE CUSTOMER REPORTED THE NEGATIVE RESULT TO THE CLINICAL PHYSICIAN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: NON-PREGNANT WOMEN < 5 MIU/ML): PATIENT ID #2 INITIAL B-HCG RESULT = 30.19 MIU/ML; REPEAT RESULT = < 1.20 MIU/ML THE COLLOIDAL GOLD METHOD WAS USED, AND THE RESULT OBTAINED WAS NEGATIVE. THE CUSTOMER REPORTED THE NEGATIVE RESULT TO THE CLINICAL PHYSICIAN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383324 ARCHITECT TOTAL B-HCG REAGENT KIT 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, ISR54105| ARC I2000SR INST, 03M74-02, ISR54105