BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-360

    MDR report key: 6063159 · Received October 28, 2016

    Report

    Report Number
    3005529799-2016-00014
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 22, 2016
    Report Date
    October 28, 2016
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 10/06/2016 TOSOH BIOSCIENCE, INC. NOTIFIED THAT ON (B)(6) 2016 A SPECIMEN WAS TESTED SEVERAL TIMES FOR BETA HCG ON A TOSOH AIA-360 ANALYZER AND THE RESULTS DID NOT CORRELATE. QCS WERE ALL WITHIN ACCEPTABLE RANGE. ON (B)(6) 2016 SPECIMEN RUN AT 9:51 AM FOR BHCG RESULT = 81.9 MIU/ML; SPECIMEN RERUN AT 10:39 AM RESULT = 0.9 MIU/ML; SPECIMEN RERUN AT 11:28 AM RESULT =1.0 MIU/ML. ON (B)(6) 2016 SPECIMEN RUN AT 10:24 AM IN A GROUP OF OTHER SAMPLES RESULT = 28.7 MIU/ML. ON (B)(6) 2016 SPECIMEN RERUN RESULT = <0.5 MIU/ML. UNKNOWN DATE SPECIMEN REDRAWN AND RERUN RESULT = <0.5 MIU/ML. ROOT CAUSE: FAILURE OR ERROR IN DILUENT DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715636 TOSOH AIA-360 AIA-360 KHO TOSOH HI-TEC AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other