BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE REAGENT KIT

    MDR report key: 22749616 · Received August 8, 2025

    Report

    Report Number
    3008344661-2025-00110
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MKW
    UDI-DI
    00380740160463
    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 FOR FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CYCLOSPORINE 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 69565FZ01. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CYCLOSPORINE REAGENT KIT FOR LOT NUMBER 69565FZ01 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    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 3R30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75 WITH 510K/PMA/BLA NUMBER K080751 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP SUBMISSION SEND TO UPDATE SECTION H6: ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE TO A090810 FROM A090809.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT = <6.7 NG/ML, REPEAT RESULT = <6.7 NG/ML THE PATIENT'S HISTORICAL RESULT WAS 500.3 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT = <6.7 NG/ML, REPEAT RESULT = <6.7 NG/ML THE PATIENT'S HISTORICAL RESULT WAS 500.3 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999422 ARCHITECT CYCLOSPORINE REAGENT KIT CYCLOSPORINE MKW ABBOTT IRELAND DIAGNOSTICS DIVISION 69565FZ01 00380740160463

    Patients

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