BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 7330281 · Received March 12, 2018

    Report

    Report Number
    1628664-2018-00104
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 18, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) A LEAKING SYRINGE ASSEMBLY (PART NUMBER 7-77650-05); A MANIFOLD KIT VALVE (PART NUMBER 7-77612-03); A 2-WAY BYPASS VALVE (PART NUMBER 7-200607-01) WERE IDENTIFIED AND REPLACED. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED A SERVICE TICKET (05-MAR-2018) FOR DAILY MAINTENANCE ERRORS. AT THAT TIME THE FSE REPLACED THE SOLENOID, MANIFOLD MOUNT, TESTED, WITH KEYS (PN 7-205710-01) FOR THE WZ UPPER MANIFOLD TO RESOLVE THE ISSUE. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING DISCREPANT RESULTS SINCE THE PARTS WERE REPLACED. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS; TROUBLESHOOTING OF I SYSTEMS; ELEVATED AND ERRATIC SAMPLE RESULTS, INCLUDING, BUT NOT LIMITED TO, LEAKING SYRINGE ASSEMBLIES OR VALVES AND INADEQUATE BUFFER DISPENSE AT THE WASH ZONE. THE I1000 SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR REPLACING THE SYRINGE ASSY (ROHS); 2-WAY BYPASS VALVE; MANIFOLD KIT VALVE; AND THE SOLENOID, MANIFOLD MOUNT, TESTED, WITH KEYS. THE ARCHITECT CYCLOSPORINE PACKAGE INSERT PROVIDES INFORMATION FOR SAMPLE HANDLING, INTERPRETATION OF RESULTS, AND PERFORMANCE CHARACTERISTICS. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO TREND FOR THE SYRINGE ASSEMBLY; THE MANIFOLD KIT VALVE; THE 2-WAY BYPASS VALVE; OR THE SOLENOID, MANIFOLD MOUNT, TESTED, WITH KEYS. A REVIEW OF THE ARCHITECT I1000SR TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ERRATIC RESULTS DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE SYRINGE ASSEMBLY (PART NUMBER 7-77650-05); THE MANIFOLD KIT VALVE (PART NUMBER 7-77612-03); THE 2-WAY BYPASS VALVE (PART NUMBER 7-200607-01); THE SOLENOID, MANIFOLD MOUNT, TESTED, WITH KEYS (PN 7-205710-01); OR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4). THERE WAS NO ADDITONAL PATIENT INFORMATION OBTAINED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2018, (B)(6), INITIAL = 308 / REPEAT AFTER QUESTIONED BY PHYSICIAN = 141 / 130NG/ML (NORMAL RANGE = 100-250; CRITICAL >300). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173736 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1