BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 5913522 · Received August 30, 2016

    Report

    Report Number
    1628664-2016-00220
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    August 5, 2016
    Report Date
    April 7, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY REVIEWING THE C802159 SERVICE HISTORY, COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, AND A REVIEW OF LABELING. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE ACCOUNT AND INDICATED THE CUSTOMER PERFORMED QUARTERLY MAINTENANCE TO INCLUDE REPLACING THE WORN OUT O-RING, SAMPLE/WASH SYRINGE. THE COMPLAINT TEXT STATED THAT CUVETTE NOZZLE #1 WAS CLOGGED WITH PAPER AND COULD BE RELATED TO THE RESULT ISSUE. THE CUSTOMER CLEANED THE CLOGGED NOZZLE AND PERFORMED THE AS NEEDED PROCEDURE 2134 (CHANGE WATER BATH). A REVIEW OF THE ARCHITECT C802159 SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY ANY TREND OF THE O-RING, SAMPLE/WASH SYRINGE ((B)(4)), THE NOZZLE #1, #4, AND #5 (ROHS) (PN 7-93256-02), OR THE ARCHITECT C8000 RELATED TO THE COMPLAINT ISSUE OF DISCREPANT RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES COMPONENT REPLACEMENT AND TROUBLESHOOTING FOR FALSELY ELEVATED RESULTS. THE CORRECTIVE ACTIONS INCLUDE BUT ARE NOT LIMITED TO: EXAMINE SAMPLES FOR FIBRIN OR OTHER LARGE PARTICLES, RERUN THE SAMPLE, REPLACE THE SYRINGE O-RING AND SEAL TIPS, PERFORM MONTHLY MAINTENANCE PROCEDURE 6018 CLEAN CUVETTE WASHER NOZZLES, AND CONTACT YOUR AREA CUSTOMER SUPPORT. BASED ON THIS INVESTIGATION NO MALFUNCTION OR DEFICIENCY OF THE O-RING, SAMPLE/WASH SYRINGE ((B)(4)), THE NOZZLE #1, #4, AND #5 (PN 7-93256-02), OR THE ARCHITECT C8000 WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY INCREASED CALCIUM RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2016, INITIAL = 2.03MMOL/L / REPEAT = 5.32 / THIRD RUN = 2.03MMOL/L (NORMAL RANGE 2.10-2.55MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566790 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # UNKNOWN