BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 5749054 · Received June 24, 2016

    Report

    Report Number
    1628664-2016-00180
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Report Date
    April 7, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE ARCHITECT I1000SR ANALYZER. THE FSE FOUND AND REPLACED A LEAKING TRIGGER MANIFOLD KIT VALVE (LIST 7-77612-03) AND ONE LEAKING TRIGGER NO. 4 TWO-WAY BYPASS VALVE (LIST 7-200607-01). THE PARTS WERE DEEMED WORN FROM NORMAL USE. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY PACKAGE INSERT CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE WAS ADDRESSED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY DECREASED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER. AN INITIAL RESULT OF 0.0 NG/L WAS GENERATED AND REPORTED FROM THE LAB. THE SAMPLE WAS THEN TESTED ON ANOTHER ARCHITECT ISYSTEM IN THE LAB AND GENERATED A RESULT OF 49.9 NG/L. A CORRECTED REPORT WAS ISSUED. A FIELD SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401725 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1