BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8789870 · Received July 15, 2019

    Report

    Report Number
    1628664-2019-00498
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBSERVED THE CUVETTE WASH PUMP BELLOWS WERE LEAKING. THE CUSTOMER REPLACED THE BELLOWS (BELLOWS ONLY (ROHS) PN 2-89054-02) AND THE ISSUE WAS RESOLVED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT, SERIAL NUMBER (SN) (B)(6) SERVICE HISTORY DID NOT REVEAL ANY OTHER REPORTS OF DISCREPANT OR INCONSISTENT RESULTS HAVE BEEN RECEIVED SINCE THE BELLOWS WERE REPLACED. A REVIEW OF HISTORICAL DATA FOR THE BELLOWS FOUND NO TRENDS OR SYSTEMIC ISSUES. A REVIEW OF THE MONTHLY PRODUCT MONITORING REVIEW FOR C16000 SYSTEMS FOUND NO SYSTEMIC ISSUES OR TRENDS FOR ERRATIC/DISCREPANT RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND C16000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDE ADEQUATE LABELING REGARDING PATIENT RESULT FLAGGING, LIMITATIONS OF RESULT INTERPRETATION, MAINTENANCE, COMPONENT REPLACEMENT, ERROR CODES, AND TROUBLESHOOTING THE REPORTED ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT, SN (B)(6), OR THE BELLOWS, BELLOWS ONLY (ROHS) PART NUMBER 2-89054-02.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID(B)(6) MG = 2.90MMOL/L / REPEATED = 0.81 / 0.82 / 0.82 / 0.80MMOL/L (NORMAL RANGE 0.66-1.07MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583049 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CLIN CHEM MAGNESIUM, LIST # 03P68-21| CLIN CHEM MAGNESIUM, LIST # 03P68-21,| LOT # 69367UN19| LOT# 69367UN19| CLIN CHEM MAGNESIUM, LIST # 03P68-21,| LOT # 69367UN19