BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE REAGENT KIT

    MDR report key: 22968723 · Received September 4, 2025

    Report

    Report Number
    3008344661-2025-00125
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 22, 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

    A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03R30-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75, WITH 510K/PMA/BLA NUMBER K080751. 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, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CYCLOSPORINE ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY REGARDING COMMONALITIES FOR COMPLAINT LOT AND ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73066FZ01. A DEVICE HISTORY RECORD REVIEW SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING WAS PERFORMED USING A RETAINED KIT OF THE COMPLAINT LOT. ALL ACCEPTANCE CRITERIA WERE MET AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE LABELLING ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CYCLOSPORINE REAGENT LOT 73066FZ01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT CYCLOSPORINE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID: (B)(6) WAS TESTED WITH AN UPGRADED CYCLOA REAGENT, THE RESULT WAS 113.6NG/ML. WHEN THE SAMPLE WAS RETESTED, THE RESULT WAS 120.1NG/ML, HISTORICAL RESULTS: ON (B)(6), 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 190.4NG/ML. ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 213.8NG/ML. PATIENT DATA: BONE MARROW TRANSPLANT PATIENT SINCE (B)(6) 2025. THE CUSTOMER CONFIRMED THAT THERE WERE NO RECENT ADJUSTMENTS IN DRUG DOSES. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT CYCLOSPORINE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID: (B)(6) WAS TESTED WITH AN UPGRADED CYCLOA REAGENT, THE RESULT WAS 113.6NG/ML. WHEN THE SAMPLE WAS RETESTED, THE RESULT WAS 120.1NG/ML, HISTORICAL RESULTS: ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 190.4NG/ML. ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 213.8NG/ML. PATIENT DATA: BONE MARROW TRANSPLANT PATIENT SINCE (B)(6) 2025. THE CUSTOMER CONFIRMED THAT THERE WERE NO RECENT ADJUSTMENTS IN DRUG DOSES. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095581 ARCHITECT CYCLOSPORINE REAGENT KIT CYCLOSPORINE MKW ABBOTT IRELAND DIAGNOSTICS DIVISION 73066FZ01 00380740160463

    Patients

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