BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH AIA-900

    MDR report key: 6777842 · Received August 9, 2017

    Report

    Report Number
    8031673-2017-00005
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 10, 2019
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 28-MAY-2016 THROUGH AWARE DATE 28-JUN-2017. THERE WERE TWO (2) SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-900 OPERATOR'S MANUAL INDICATES TO CONTACT A TOSOH LOCAL REPRESENTATIVE FOR ANALYZER REPAIRS OR INFORMATION ON DISPOSAL. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE IDENTIFIER FINGERS/SENSORS REQUIRING ALIGNMENT. 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

    ON (B)(4) 2017 A FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO ALIGN AND ADJUST THE SENSOR FINGERS AND TUBE GUIDE FOR PROPER OPERATION. NO FURTHER ACTION WAS REQUIRED. TOSOH BIOSCIENCE, INC. IS CURRENTLY PERFORMING ADDITIONAL INVESTIGATION INTO THIS ISSUE WITH THIS CUSTOMER. MDR IS BEING SUBMITTED LATE BECAUSE OF DIFFICULTIES SETTING UP THE USER ACCOUNT THROUGH THE ELECTRONIC SUBMISSION GATEWAY (ESG) SYSTEM. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED INTERMITTENTLY GETTING TWO PATIENT RESULTS UNDER THE SAME BARCODE. THE CUSTOMER REPORTED HAVING INTERMITTENT BARCODE ERRORS AS WELL. THE CUSTOMER REPORTED USING 12MM TUBES; SUSPECT TUBES ARE NOT HELD ALIGNED AS IDENTIFIER SENSOR IDENTIFIES THE SPECIMEN TUBES, CUPS OR TEST CUPS HOLDERS.

    Additional Manufacturer Narrative · 1

    (B)(4) PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563615 TOSOH AIA-900 AIA-900 KHO TOSOH HI-TEC AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1