BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 9765239 · Received February 27, 2020

    Report

    Report Number
    1628664-2020-00083
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    December 27, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = (B)(6). THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2020-00019 UNDER A DIFFERENT SUSPECT DEVICE. DURING THE REQUEST SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND TRANSPARENT GEL STUCK TO THE SAMPLE PROBE AND FOUND CRYSTALLIZATION AROUND THE INSIDE OF R1 AND R2 PLUNGERS. THE FSR REPLACED AND CALIBRATED THE SAMPLE PROBE, REPLACED THE SYRINGE ASSY (ROHS) PART NUMBER 7-77650-06, REPLACED THE VALVE, MANIFOLD KIT (ROHS) PART NUMBER 7-77612-03, AND PERFORMED A WZ1 VALVES PRESSURE CHECK, WHICH RESOLVED THE ISSUE. THE FSR VERIFIED THE SYSTEM FUNCTION WITH A CONTROL. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF SERVICE HISTORY OF THE ARCHITECT I2000, SERIAL NUMBER (B)(4) VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED SINCE REPLACEMENT OF THE PARTS. A REVIEW OF THE ARCHITECT I2000SR PLATFORM FOUND NO SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. A 12-MONTH REVIEW IDENTIFIED NO TRENDS OF THE SYRINGE ASSY (ROHS) OR THE VALVE, MANIFOLD KIT (ROHS). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000 ANALYZER, SERIAL NUMBER (B)(4), THE SYRINGE ASSY (ROHS) PART NUMBER 7-77650-06, OR THE VALVE, MANIFOLD KIT (ROHS) PART NUMBER 7-77612-03.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) INITIAL =119.87NG/ L / SECOND SAMPLE 3 HOURS LATER (B)(6) = <5NG/L / FIRST SAMPLE RETEST =<5NGL. THE (B)(6) YEAR OLD MALE HAD AN EKG PERFORMED, ADDITIONAL BLOOD DRAWS, AND WAS IN THE HOSPITAL FOR 3 HOURS. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225675 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR