BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION

    MDR report key: 7328645 · Received March 9, 2018

    Report

    Report Number
    2916205-2018-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 9, 2018
    Manufacturer
    AGILENT TECHNOLOGIES MANUFACTURING GMBH & CO KG
    Product Code
    KIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE INVESTIGATED THE ISSUE REPORTED, BASED ON OUR INVESTIGATION WE FOUND THAT A USER ERROR IS THE ROOT CAUSE OF THE REPORTED PROBLEM. THE CUSTOMER HAD PLACED THE UPPER WELL PLATE IN STANDARD POSITION IN THE INSTRUMENT, CREATING THE WORKLIST ACCORDINGLY BUT HAD SELECTED THE "BACK TO FRONT ORIENTATION" FEATURE FOR THE UPPER PLATE CONFIGURATION, I.E. TO DENOTE THAT THE PLATE IS INSTALLED AT 180 DEGREES TO THE STANDARD POSITION. THE INSTRUMENT PROCESSED THE SAMPLES ACCORDINGLY. THE PATIENT ASSIGNMENTS PER WORKLIST DID NOT MATCH THE SAMPLE PROCESSING ORDER CONFIGURED.

    Description of Event or Problem · 1

    IT WAS REPORTED PER THE CUSTOMER THAT THE 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER K1367E CLINICAL EDITION DID NOT PICK UP THE SAMPLES FROM THE CORRECT WELL POSITIONS. AFTER INVESTIGATION, THE ISSUE WAS ATTRIBUTED TO USER ERROR. THE CUSTOMER RECALLED THE INCORRECT RESULTS ON (B)(6) 2018 AND RESUBMITTED CORRECTED REPORTS ON (B)(6) 2018. ON (B)(6) 2018, THE CUSTOMER REPORTED THAT THE USER ERROR REOCCURRED. THE CUSTOMER NOTICED THE BACK TO FRONT PIPETTING SEQUENCE FOR THE UPPER PLATE AND ABORTED THE RUN. INCORRECT RESULTS WERE NOT RELEASED. THE CUSTOMER SET UP A NEW RUN AND RELEASED THE CORRECT RESULTS (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172463 K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION KIE AGILENT TECHNOLOGIES MANUFACTURING GMBH & CO KG K1367E

    Patients

    Seq Age Sex Outcome Treatment
    1