BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8409930 · Received March 11, 2019

    Report

    Report Number
    1628664-2019-00190
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 11, 2019
    Report Date
    April 12, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT BY THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR), THE BELLOWS WERE REPLACED TO RESOLVE THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT OR FALSELY ELEVATED RESULTS REPORTED AFTER THE BELLOWS, PART NUMBER 2-89054-02, WAS REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE INSTRUMENT SERVICE HISTORY REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED ON THE ARCHITECT, SERIAL NUMBER C461413. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF HISTORICAL DATA FOR THE PART REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES ASSOCIATED WITH THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER 2-89054-02. A REVIEW OF THE ARCHITECT C16000 PLATFORM FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C4000 SERVICE AND SUPPORT MANUAL, PROVIDES ADEQUATE INFORMATION, TROUBLESHOOTING, AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS; INCLUDING, BUT NOT LIMITED TO, THE REPLACEMENT OF THE BELLOWS PERFORMED BY THE FSR. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT, SERIAL NUMBER C461413 OR THE BELLOWS, PART NUMBER 2-89054-02.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019, PT # 1 INITIAL = 3.3MG/DL / 1.3 / REPEATED ON SECOND INSTRUMENT = 1.3MG/DL (NORMAL RANGE 1.9 - 2.6 MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201056 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-21| CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-21| LOT # 95220UN18| LOT 95220UN18