BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 12016398 · Received June 17, 2021

    Report

    Report Number
    3016438761-2021-00222
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND REPLACED THE ARC, PROBE, PROBE NEXT R, VALVE, MANIFOLD KIT (ROHS), SYRINGE ASSY, AND THE MOTOR, SHUTTER OR WZ (ROHS), WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6), SERVICE HISTORY REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND COMPONENT REPLACEMENT. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. A 12-MONTH REVIEW FOR THE PARTS REPLACED DID NOT IDENTIFY ANY TRENDS. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE ARCHITECT ANALYZER OR THE PARTS REPLACED. THE CURRENT PRODUCT MONITORING REVIEW FOUND NO SYSTEMIC ISSUES OR TRENDS FOR DISCREPANT RESULTS AND NO SYSTEMIC ISSUES FOR THE ARCHITECT I2000SR AS DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6), OR THE ARC, PROBE (08C94-47), PROBE NEXT R (03R85-01), VALVE, MANIFOLD KIT (ROHS) (7-77612-03), SYRINGE ASSY (7-77650-08) OR MOTOR, SHUTTER OR WZ (ROHS) (7-78851-01) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = SID (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. 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 ARCHITECT CA19-9 RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6). IT IS UNKNOWN IF THE PATIENT IS DIAGNOSED WITH PANCREATIC CANCER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918187 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC CA19-9XR 500T ROW, 02K91-39, 22025M800| ARC CA19-9XR 500T ROW, 02K91-39, 22025M800| ARC CA19-9XR 500T ROW, 02K91-39, 22025M800