BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8446722 · Received March 24, 2019

    Report

    Report Number
    1628664-2019-00248
    Event Type
    Malfunction
    Date Received
    March 24, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 16, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SUBSEQUENT SITE VISIT, THE ABBOTT FIELD SERVICE ENGINEER (FSE) OBSERVED BUBBLES IN THE INTERNAL PROBE WASH PUMP. THE FSE REPLACED THE BELLOWS ONLY BELLOWS (ROHS) (PART NUMBER 2-89054-02) AND THE AERO C8K POPPET VALVE (LIST NUMBER 09D36-02), WHICH RESOLVED THE ISSUE. AFTER PARTS REPLACEMENT, QC WAS PERFORMED AND FOUND WITHIN ACCEPTABLE RANGES. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C4000, SERIAL NUMBER (B)(4), SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING ERRATIC OR DISCREPANT GLUCOSE, TOTAL BILIRUBIN, OR QC RESULTS SINCE THE PARTS WERE REPLACED. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AS WELL AS INFORMATION REGARDING TROUBLESHOOTING ERRATIC/DISCREPANT RESULTS. THE MANUAL ALSO PROVIDES INSTRUCTION FOR THE REMOVAL, REPLACEMENT, AND VERIFICATION OF THE AERO C8K POPPET VALVE. THE ARCHITECT C4000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTION FOR THE REMOVAL, REPLACEMENT, AND VERIFICATION OF THE BELLOWS ONLY BELLOWS (ROHS). A 12-MONTH REVIEW FOR SIMILAR COMPLAINTS IDENTIFIED NO TRENDS OF THE BELLOWS ONLY BELLOWS (ROHS) OR THE AERO C8K POPPET VALVE. A REVIEW OF THE C4000 PLATFORM TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES TRENDS ASSOCIATED WITH THE DISCREPANT RESULTS DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C4000, SERIAL NUMBER (B)(4), THE BELLOWS ONLY BELLOWS (ROHS) (PART NUMBER 2-89054-02), OR THE AERO C8K POPPET VALVE (LIST NUMBER 09D36-02).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = (B)(6). AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED GLUCOSE AND TOTAL BILIRUBIN RESULTS ON ONE PATIENT ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(6) = GLUCOSE = 5 MG/DL 189 / 135 / 157 MG/DL; AND T. BILI = <0.1 MG/DL 0.28 MG/DL 0.36 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239843 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1