BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 7479500 · Received May 2, 2018

    Report

    Report Number
    1628664-2018-00171
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT, THE ABBOTT FIELD SERVICE ENGINEER (FSE) OBSERVED LEAKING FROM THE MANIFOLD DURING NORMAL USE, SO THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612 WAS REPLACED. IN ADDITION, THE PROBE, AND VALVE, BYPASS, 2 WAY WERE ALSO REPLACED. THE FSE VERIFIED THE SYSTEM FUNCTION BY PERFORMING SUCCESSFUL CALIBRATIONS AS WELL AS A SUCCESSFUL CONTROL RUN. NO ADDITIONAL DISCREPANT RESULTS WERE REPORTED AFTER THE PARTS WERE REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT (B)(4) SERVICE HISTORY WAS PERFORMED AND IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL (201970-116) PROVIDE ADEQUATE INFORMATION FOR THE TROUBLESHOOTING AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS, INCLUDING, BUT NOT LIMITED TO, THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03. A REVIEW OF TICKETS FOR THE ARCHITECT I1000SR AND THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03 REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ERRATIC RESULT ISSUE DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4), OR THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO FURTHER PATIENT INFORMATION OBTAINED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PHYSICIAN QUESTIONED ARCHITECT TOTAL PSA RESULTS ON THREE PATIENTS. THE RESULTS PROVIDED WERE: S1 = 0.79/PREVIOUS = 11; S2 = 1.3/PREVIOUS = 0.7; S3 = 5.9/PREVIOUS 0.25. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321542 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TOTAL PSA, LIST # 06C06-27,| ARCHITECT TOTAL PSA, LIST # 06C06-27,| LOT # 82044FN00| LOT # 82044FN00