BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8778243 · Received July 10, 2019

    Report

    Report Number
    1628664-2019-00482
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED THE CUVETTE WASHER NOZZLE #1 WAS OVERFLOWING AND REPLACED THE TUBING, PERISTALTIC HEAD (ROHS) AND HCW PUMP OUT TO T FTG (ROHS) WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A 12-MONTH SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO TRENDS OF THE TUBING, PERISTALTIC HEAD (ROHS) AND HCW PUMP OUT TO T FTG (ROHS) WITH REGARD TO DISCREPANT PATIENT RESULTS. A REVIEW OF THE C4000 TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ERRATIC RESULT DESCRIBED IN THIS COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION, TROUBLESHOOTING, AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS. INCLUDING, BUT NOT LIMITED TO, THE REPLACEMENT OF THE TUBING, PERISTALTIC HEAD (ROHS) AND HCW PUMP. THE ARCHITECT C4000 SYSTEM SERVICE AND SUPPORT MANUAL CONTAINS ADEQUATE INFORMATION FOR THE REMOVAL, REPLACEMENT, AND VERIFICATION OF THE TUBING, PERISTALTIC HEAD AND THE HCW PUMP. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE TUBING, PERISTALTIC HEAD (ROHS) (PART NUMBER 7-35009685-02) OR THE HCW PUMP OUT TO T FTG (ROHS) (PART NUMBER 7-205612-01).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019, SID (B)(6) = 2.79MG/DL / REPEAT = 1.12MG/DL (NORMAL RANGE 1.6-2.6MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571624 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 CLIN CHEM MAGNESIUM, LN # 03P68-22| CLIN CHEM MAGNESIUM, LN 03P68-22,| LOT # 69365UN18| LOT # 69365UN18