BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8733204 · Received June 26, 2019

    Report

    Report Number
    1628664-2019-00462
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 22, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A SITE VISIT BY ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) TROUBLESHOOTING WAS PERFORMED WHICH INCLUDED REPLACING PARTS AND PERFORMING MAINTENANCE TO OPTIMIZE THE SYSTEM. THE FSR REPLACED THE CUVETTE DRYING TIP (LN 09D51-02) WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C16000, SERIAL NUMBER (B)(4), SERVICE HISTORY REVEALED NO ADDITIONAL REPORTS OF INCONSISTENT OR ERRATIC RESULTS. A 12-MONTH REVIEW OF HISTORICAL DATA FOR THE CUVETTE DRYING TIP REVEALED NO TRENDS OR SYSTEMIC ISSUES. THE MONTHLY PRODUCT MONITORING REVIEW FOR THE ARCHITECT C16000 SYSTEMS FOUND NO SYSTEMIC ISSUES OR TRENDS FOR ERRATIC/DISCREPANT RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE LABELING REGARDING MAINTENANCE, COMPONENT REPLACEMENT, LIMITATIONS OF RESULT INTERPRETATION, PATIENT RESULT FLAGGING, AND TROUBLESHOOTING THE REPORTED ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C16000, SERIAL NUMBER (B)(4), OR THE CUVETTE DRYING TIP (LN 09D51-02).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: PATIENT IDENTIFIER - MULTIPLE = (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP 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 SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND CALCIUM (CA) ON 5 PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(6), K= 2.5 / 4.0 (3.5-5.1 MEQ/L), CL = 67 / 108 (98-107MEQ/L); SID (B)(6) NA=107 / 140(136-145MEQ/L); SID (B)(6) NA = 101 / 137; SID (B)(6) CL=68 / 109; AND SID (B)(6) NA = 116 / 134. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528080 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE, LIST # 09D28-04, LOT #| ICT MODULE, LIST 09D28-04| LOT = UNKNOWN