BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-600II

    MDR report key: 5896186 · Received August 23, 2016

    Report

    Report Number
    3005529799-2016-00011
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 9, 2016
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 07/27/2016 TOSOH BIOSCIENCE, INC. RECEIVED INFORMATION THAT ON (B)(6) 2016 TROPONIN QCS WERE RUN ON A TOSOH AIA-600II ANALYZER. THE QCS WERE ERRATIC BUT FINALLY HAD QC RESULTS THAT WERE WITHIN THE ACCEPTABLE RANGE SO RAN A PATIENT SPECIMEN FOR TROPONIN, RESULT = 0.42 NG/ML. THE SAME SPECIMEN WAS RETESTED, RESULT = 0.58 NG/ML WHICH WAS REPORTED. PATIENT WAS REDRAWN AND RESULT WAS < L. INITIAL REPORTED RESULT WAS DETERMINED TO BE INCORRECT. THE INVESTIGATION DETERMINED THAT DILUTING SOLUTION WAS NOT BEING USED AS THE SAMPLE DILUENT. WATER WAS BEING USED AS SAMPLE DILUENT INSTEAD OF THE PROPER DILUTING SOLUTION. ROOT CAUSE: OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549686 TOSOH AIA-600II 600II KHO TOSOH HI-TEC 600II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other