BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 10737035 · Received October 26, 2020

    Report

    Report Number
    3016438761-2020-00262
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = SID= (B)(6) AND NO SID FOR SECOND PATIENT. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE THE CUSTOMER REPORTED A FALSELY ELEVATED TROPONIN RESULT ON THE ARCHITECT I2000SR; SERIAL NUMBER (B)(4). THROUGH TROUBLESHOOTING THE CUSTOMER REPLACED THE VALVE, MANIFOLD KIT (ROHS) (LIST NUMBER 7-77612-03), AND ACCUMULATOR TUBE ASSEMBLY, (ROHS) PN 7-95548-01 THEN VERIFIED THE SYSTEM PERFORMED WITHIN SPECIFICATION WITHOUT ANY ISSUE. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING ELEVATED TROPONIN RESULTS SINCE THE PARTS WERE REPLACED. A REVIEW OF THE I2000SR TRACKING AND TRENDING DATA FOUND NO TRENDS ASSOCIATED WITH THE CUSTOMER ISSUE DESCRIBED IN THIS COMPLAINT. A REVIEW FOR SIMILAR COMPLAINTS IDENTIFIED NO TRENDS FOR THE MANIFOLD KIT, AND ACCUMULATOR TUBE ASSEMBLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIKELY CAUSE PART, OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR; SERIAL NUMBER (B)(4), OR THE MANIFOLD KIT (ROHS) (LIST NUMBER 7-77612-03) AND ACCUMULATOR TUBE ASSEMBLY, (ROHS) PN 7-95548-01.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2020, SID: (B)(6); INITIAL TROPONIN=0.75 NG/ML/ REPEATED ON (B)(6) 2020=NORMAL VALUE (NO ACTUAL RESULTS PROVIDED). SECOND PATIENT: 0.083 NG/ML/ (B)(6) 2020 REPEATED ON SAME INSTRUMENT =0.686 NG/ML/REPEATED ON DIFFERENT INSTRUMENT=0.089 NG/ML. NORMAL RANGE FOR TROPONIN= 0.0 TO 0.05 NG/ML, CRITICAL VALUE= >0.5 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199908 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1