BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 15106307 · Received July 26, 2022

    Report

    Report Number
    3016438761-2022-00340
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 19, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) RESOLVED THE ISSUE BY REPLACING THE CMIA READER, METAL CASE, TESTED (7-201909-03), THE 100UL TRIGGER PUMP (ROHS) (7-96344-02) AND THE PRE-TRIGGER PUMP (ROHS) (7-96345-02). THE TRIGGER AND PRETRIGGER PUMPS WERE REPLACED DUE TO LEAKING. PART REPLACEMENT RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTION FOR THE REMOVAL, REPLACEMENT, AND VERIFICATION OF THE CMIA READER, METAL CASE, TESTED (7-201909-03), 100UL TRIGGER PUMP (ROHS) (7-96344-02) AND THE PRE-TRIGGER PUMP (ROHS) (7-96345-02). TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. BASED ON ALL REVIEWED DATA, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I1000SR INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULT WAS 700 NG/ML, REPEATED ON ANOTHER INSTRUMENT AND THE RESULT WAS 100 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342103 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC CYCLO RGT 100, 01L75-25, UNKNOWN| ARC CYCLO RGT 100, 01L75-25, UNKNOWN