BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 8955868 · Received September 3, 2019

    Report

    Report Number
    1628664-2019-00592
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE, THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING BY REPLACING ALL THE LEAKING TRIGGER AND PRE-TRIGGER VALVES (VALVE, MANIFOLD KIT (PN 7-77612-03), CLEANING THE MANIFOLD BODY, CLEANING THE PROCESS PATH (PATH, PROCESS, I2000SR (PN 7-94086-01) AND DISC, AND CALIBRATING THE PROBES. REPLACEMENT OF THE VALVES AND CLEANING OF THE PROCESS PATH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS SINCE THE VALVES WERE REPLACED AND THE PATH, PROCESS, I2000SR (PN 7-94086-01) WAS CLEANED. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION AND TROUBLESHOOTING CONCERNING ERRATIC / DISCREPANT RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL ALSO ADDRESSES THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERROR CODES 5106 AND 5900. THE ARCHITECT I SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES ADEQUATE INFORMATION FOR REMOVAL AND REPLACEMENT OF THE VALVE, MANIFOLD KIT (PN 7-77612-03) AND CLEANING OF THE PATH, PROCESS, I2000SR (PN 7-94086-01). A REVIEW OF SIMILAR COMPLAINTS FOR THE VALVE, MANIFOLD KIT AND PATH, PROCESS, I2000SR IDENTIFIED NO TRENDS WITH REGARD TO DISCREPANT PATIENT RESULTS. A REVIEW OF THE ARCHITECT I2000SR SYSTEM TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ERRATIC RESULT DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6), THE VALVE, MANIFOLD KIT (PN 7-77612-03), OR THE PATH, PROCESS, I2000SR (PN 7-94086-01).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: PATIENT IDENTIFIER: (B)(6). THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS ON 3 PATIENTS AFTER RESULTS WERE REVIEWED AFTER A SERVICE CALL FOR MULTIPLE ERROR CODES. THE RESULTS PROVIDED WERE: (B)(6) = 1.7 NG/ML / REPEATED ON SECOND I2000 ANALYZER = 308 NG/ML; (B)(6) = 0.0 NG/ML / REPEAT ON 2ND I2000 = 308 NG/ML; (B)(6) = 0.6 NG/ML / REPEAT ON I2000= 206 NG/ML (REFERENCE RANGE 100-200NG/ML). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748096 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT CYCLOSPORINE, LN 01L75-25,| ARCHITECT CYCLOSPORINE, LN 01L75-25,| LOT # 01053M800| LOT # 01053M800