BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 10720780 · Received October 22, 2020

    Report

    Report Number
    3016438761-2020-00253
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3008344661-2020-00068-00 UNDER A DIFFERENT SUSPECT DEVICE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SITE VISIT, INSPECTED THE INSTRUMENT, AND OBSERVED A LEAK IN THE TRIGGER AND SAMPLE BUFFER PUMPS. THE FSE REPLACED THE TRIGGER AND PRE-TRIGGER VALVES, AND VORTEXER 3. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS, AS DESCRIBED IN THIS COMPLAINT DOCUMENTED AFTER THE VORTEXER, STABILIZED (ROHS) PN 7-76656-05 AND VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 WERE REPLACED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS, LIMITATIONS, AND TROUBLESHOOTING OF THE FLUIDICS SUB-SYSTEM, AND COMPONENT REPLACEMENT. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF DEPRESSED CONCENTRATION, AND ERRATIC SAMPLE RESULTS. THE ARCHITECT I SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR THE REMOVAL AND REPLACEMENT OF THE VORTEXER, STABILIZED (ROHS) PN 7-76656-05 AND VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT I2000SR TRACKING, AND TRENDING DATA DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE, OR DEFICIENCY OF THE VORTEXER, STABILIZED (ROHS), VALVE, MANIFOLD KIT (ROHS), OR THE ARCHITECT (B)(4) INSTRUMENT SERIAL (B)(4) WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL PSA RESULTS GENERATED ON THE ARCHITECT I2000SR INSTRUMENT ON ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6)GENERATED A RESULT OF < 0.01 UG/L. TWO WEEKS EARLIER THE SAME PATIENT SID (B)(6) GENERATED A RESULT OF 1.085 UG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187780 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1