BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-900

    MDR report key: 4172242 · Received October 3, 2014

    Report

    Report Number
    3005529799-2014-00013
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 3, 2014
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 (ORIGINALLY REPORTED AS 2013) TOSOH BIOSCIENCE WAS NOTIFIED THAT AN ACCOUNT HAD TESTED TWO PATIENT SPECIMENS FOR TROPONIN, SECOND GENERATION ON THE TOSOH AIA-900 ANALYZER. INITIAL RESULTS WERE REPORTED AS POSITIVE AND WERE QUESTIONED BY THE PHYSICIAN. REPEAT RESULTS WERE NEGATIVE. ALL CQS WERE WITHIN ACCEPTABLE RANGES. ROOT CAUSE: UNKNOWN, UNABLE TO DETERMINE THE ROOT CAUSE OF THE ERRORS. TOSOH BIOSCIENCE FIELD SERVICE ENGINEER PERFORMED ON-SITE SERVICE BUT DID NOT IDENTIFY ANY THING THAT COULD HAVE DEFINITIVELY CAUSED THE ERRORS. THE INSTRUMENT HAD SET IDLE FOR SEVERAL HOURS PRIOR TO ANALYSIS OF BOTH SAMPLES, AND AN AIR BUBBLE WAS FOUND IN THE SUBSTRATE SYRINGE. IMPROPER START-UP OF ANALYZER COULD HAVE BEEN THE CAUSE OF THE AIR BUBBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617846 TOSOH AIA-900 TOSOH AIA-900 KHO TOSOH BIOSCIENCE, INC. AIA-900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1