BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 6906599 · Received September 29, 2017

    Report

    Report Number
    8031673-2017-00038
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    August 30, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 30-AUG-2017 A FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER IN REPLACING THE BENT SAMPLE NEEDLE AND VERIFIED ALIGNMENT. THE CUSTOMER START-UP THE AIA-360 SYSTEM, RAN QUALITY CONTROLS, AND SAMPLES WITHOUT ANY ISSUES. THE AIA-360 WAS WORKING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO OTHER SIMILAR COMPLAINTS DURING THIS TIME PERIOD. THE AIA-360 UNDER SAFETY PRECAUTIONS STATES TO ENSURE TO REMOVE THE CAP OF THE PRIMARY TUBES BEFORE LOADING THE CAROUSEL. OPERATION WILL DAMAGE THE PARTS IN THE AIA-360 WITH A CAP ATTACHED. THE PROBABLE CAUSE OF THE BENT SAMPLE NEEDLE WAS DUE TO HUMAN ERROR.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED ACCIDENTLY PLACING A CAPPED SAMPLE, WHICH CAUSED THE SAMPLE NEEDLE TO BEND ON THE AIA-360 SYSTEM. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON INTACT PARATHYROID HORMONE (IPTH). ON 30-AUG-2017 A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Additional Manufacturer Narrative · 1

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Additional Manufacturer Narrative · 1

    (B)(4), PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685798 AIA-360 AIA-360 KHO TOSOH HI-TEC AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1