BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 6942577 · Received October 11, 2017

    Report

    Report Number
    8031673-2017-00049
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 11, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 12-SEP-2017 A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE SAMPLE NOZZLE ASSEMBLY WAS BENT. THE SAMPLE NOZZLE ASSEMBLY WAS REPLACED. THE INSTRUMENT WAS OPERATING WITHOUT ANY ISSUES. A 13-MONTH COMPLAINT HISTORY REVIEW WAS PERFORMED FROM 11-AUG-2016 THROUGH (B)(6) 2017 FOR SERIAL (B)(4) FOR SIMILAR COMPLAINTS. A TOTAL OF THREE (3) COMPLAINTS WERE FOUND DURING THE SEARCHED PERIOD, INCLUDING THIS EVENT; HOWEVER, THERE WERE NO OTHER SIMILAR COMPLAINTS. THE AIA-360 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS STATES TO UNCAP PRIMARY TUBES BEFORE LOADING THE CAROUSEL. OPERATION WILL DAMAGE THE PARTS IN THE AIA-360 WITH A CAP ATTACHED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED THAT THE SAMPLE NOZZLE ASSEMBLY WAS BENT WHILE RUNNING AN HBA1C PATIENT SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE WAS RUN ON THE AIA-360 WITHOUT REMOVING THE CAP, CAUSING THE SAMPLE NOZZLE ASSEMBLY TO BEND. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON HBA1C. ON 12-SEP-2017 A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720852 AIA-360 AIA-360 KHO TOSOH HI-TEC AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1