BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE REAGENT KIT

    MDR report key: 23184261 · Received September 30, 2025

    Report

    Report Number
    3008344661-2025-00136
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 22, 2025
    Report Date
    November 5, 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

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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.

    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. 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 74465FZ01. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT OR COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED USING A RETAINED KIT OF COMPLAINT LOT 74465FZ01. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT 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 ASSAY FOR LOT 74465FZ01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DECREASED ARCHITECT CYCLOSPORINE RESULTS GENERATED FOR THREE PATIENT SAMPLES. THE CUSTOMER STATES THAT RESULTS GENERATED ON (B)(6) 2025 ARE DEPRESSED COMPARED TO RESULTS GENERATED ON (B)(6) 2025. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) 45-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT = 315.4 NG/ML, (B)(6) 2025 REPEAT RESULT = 154.88 NG/ML. (B)(6) 2025 RESULTS = 75.9 NG/ML, 78.1 NG/ML. SAMPLE ID (B)(6) 21-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT = 572.3 NG/ML, (B)(6) 2025 REPEAT RESULT = 293.88 NG/ML (B)(6) 2025 RESULTS = 140.2 NG/ML, 158 NG/ML. THIS PATIENT UNDERWENT A MEDICATION DOSAGE ADJUSTMENT, RESULTING IN A LOWER RESULT. CUSTOMER STATES THERE WAS NO HARM TO THE PATIENT, DUE TO THE MEDICATION ADJUSTMENT. SAMPLE ID (B)(6) 21-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT = 196.2 NG/ML, (B)(6) 2025 REPEAT RESULT = 104.9 NG/ML (B)(6) 2025 RESULTS = 57.9 NG/ML, 61 NG/ML. NO IMPACT OR NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DECREASED ARCHITECT CYCLOSPORINE RESULTS GENERATED FOR THREE PATIENT SAMPLES. THE CUSTOMER STATES THAT RESULTS GENERATED ON (B)(6) 2025 ARE DEPRESSED COMPARED TO RESULTS GENERATED ON (B)(6) 2025. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) 45-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT = 315.4 NG/ML, (B)(6) 2025 REPEAT RESULT = 154.88 NG/ML. (B)(6) 2025 RESULTS = 75.9 NG/ML, 78.1 NG/ML. SAMPLE ID (B)(6) 21-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT = 572.3 NG/ML, (B)(6) 2025 REPEAT RESULT = 293.88 NG/ML. (B)(6) 2025 RESULTS = 140.2 NG/ML, 158 NG/ML. THIS PATIENT UNDERWENT A MEDICATION DOSAGE ADJUSTMENT, RESULTING IN A LOWER RESULT. CUSTOMER STATES THERE WAS NO HARM TO THE PATIENT, DUE TO THE MEDICATION ADJUSTMENT. SAMPLE ID (B)(6) 21-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT = 196.2 NG/ML, (B)(6) 2025 REPEAT RESULT = 104.9 NG/ML. (B)(6) 2025 RESULTS = 57.9 NG/ML, 61 NG/ML. NO IMPACT OR NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796094 ARCHITECT CYCLOSPORINE REAGENT KIT CYCLOSPORINE MKW ABBOTT IRELAND DIAGNOSTICS DIVISION 74465FZ01 00380740160463

    Patients

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