BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8367297 · Received February 25, 2019

    Report

    Report Number
    1628664-2019-00166
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON THE SUBSEQUENT SITE VISIT, THE ABBOTT FIELD SERVICE ENGINEER (FSE) REVIEWED QC ISSUES WITH MULTIPLE B-LINE ASSAYS. THE FSE OBSERVED THE DRY NOZZLE #8 B TO VACUUM VALVE TUBING (ROHS) (LIST NUMBER 7-203117-01) WAS OBSTRUCTED AND NOT DRAINING. THE TUBING WAS CLEANED TO REMOVE THE CLOG, 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 IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AS WELL AS INFORMATION REGARDING TROUBLESHOOTING ERRATIC/DISCREPANT RESULTS. THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INFORMATION FOR REMOVAL AND REPLACEMENT OF THE DRY NOZZLE #8 B TO VACUUM VALVE TUBING. A REVIEW OF THE ARCHITECT C16000 PLATFORM DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT ISSUE DESCRIBED IN THIS COMPLAINT. A 12-MONTH SEARCH FOR SIMILAR COMPLAINTS FOR THE DRY NOZZLE #8 B TO VACUUM VALVE TUBING IDENTIFIED NO TRENDS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C16000, SERIAL NUMBER (B)(4), OR THE DRY NOZZLE #8 B TO VACUUM VALVE TUBING (ROHS) (LIST NUMBER 7-203117-01).

    Additional Manufacturer Narrative · 1

    COMPLETE INFORMATION FOR SECTION A. 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 IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED MAGNESIUM RESULTS FOR FIVE PATIENTS ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID: (B)(6) = 0.7MG/DL/1.9; SID: (B)(6) = 0.9/2.2MG/DL; SID: (B)(6) = 0.8/2.3MG/DL; SID: (B)(6) = 0.9/1.9MG/DL; SID: (B)(6) = 0.8/1.8MG/DL (NORMAL RANGE 1.5 - 2.6MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160766 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-31,| CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-31,| LOT # 31429UN18| LOT # 31429UN18| CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-31,| LOT # 31429UN18