BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIA-900

    MDR report key: 5458071 · Received February 24, 2016

    Report

    Report Number
    3005529799-2016-00001
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 28, 2016
    Report Date
    April 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TOSOH CORPORATION (B)(4). UDI - (B)(4). OPERATOR OF DEVICE: HEALTH PROFESSIONAL. OCCUPATION: HEALTH PROFESSIONAL. (B)(4). TOSOH CORPORATION (B)(4). REPORT SOURCE: HEALTH PROFESSIONAL. DATE RECEIVED BY MFR: 2/11/2016. PMA/510K: K971103 DEVICE AVAILABLE FOR EVAL: NO / RESOLVED OVER THE PHONE / NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). USAGE OF DEVICE: REUSE. THE PROBABLE CAUSE OF THE EVENT WAS DILUENT SUCTION POSITION. (B)(4), PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2016 A TROPONIN WAS TESTED ON THE TOSOH AIA-900. THE RESULT WAS 0.45 NG/ML. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN BEFORE THE POSITIVE DELTA CHECK WAS COMPLETED. THE PATIENT WAS PREPARED FOR TRANSPORT TO ANOTHER MEDICAL CENTER BASED ON THE POSITIVE RESULT. A DELTA CHECK WAS THEN RUN ON THE SPECIMEN AND THE RESULTS WERE 0.11 NG/ML AND 0.14 NG/ML (NEGATIVE). ALL QC WERE ACCEPTABLE WHEN TESTED 17 HOURS PRIOR TO THE SPECIMEN BEING TESTED. NO ABNORMALITIES WERE NOTED WITH THE PATIENT SPECIMEN. ON (B)(6) 2016 TOSOH BIOSCIENCE, INC. WAS NOTIFIED OF THE INCORRECT PATIENT RESULT REPORT. AND A TOSOH BIOSCIENCE, INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ANALYZER SERVICE, THE ANALYZER WAS INSPECTED AND CLEANED AND PRECISION TESTING WITH QC WAS COMPLETED. THE FSE WAS UNABLE TO DUPLICATE THS ISSUE. ROOT CAUSE: UNABLE TO DETERMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113012 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other