BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7130982 · Received December 19, 2017

    Report

    Report Number
    8031673-2017-00185
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 20, 2017
    Report Date
    August 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10. CORRECTED DATA IN SECTION D4 CATALOG # WAS 12278408. THE CORRECTED AIA-360 CATALOG # IS 019945. IN BOTH SECTIONS B5 AND H3/H10, THE FSE DISPATCHED DATE WAS 21-NOV-2017. THE CORRECTED DATE IS 20-NOV-2017. IN H4 DEVICE MANUFACTURE DATE WAS 01-FEB-2009. THE CORRECTED DATE IS 01-OCT-2015.

    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 (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY AND CONFIRMED THE REPORTED ISSUE. FSE RAN QUALITY CONTROLS (QC) TESTS AND OBSERVED THAT DURING THE SECOND SAMPLE OF EACH RUN, ERROR 4029 WOULD APPEAR. FSE CONDUCTED VISUAL INSPECTION AND REMOVED COVERS, ZIP TIE THAT WAS SECURED AROUND THE PULSE MOTOR (PM), OBSTRUCTIONS OR RESTRICTIONS TO THE CABLE CONNECTOR AND SENSOR CABLE. FSE THEN RE-SEATED THE CABLES AND SENSOR TO THE SENSE ELECTRONIC BOARD. QUALITY CONTROLS WERE PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES FOR ACTUATOR-RELATED ERRORS, ERROR 4029 SPEC. T-AXIS HOME NOT FOUND IS GENERATED WHEN THE HOME POSITION OF THE SPECIMEN 0-AXIS MOTOR CANNOT BE DETECTED. TROUBLESHOOTING STATES TO TURN THE POWER OFF AND ON AGAIN. IF THIS PROBLEM RECURS, TO CONTACT THE SERVICE DEPARTMENT. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS DUE TO A CABLE TIE RESTRICTING THE THETA AXIS MOVEMENT FOR SAMPLING ASSEMBLY.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING ERROR 4029 T-AXIS HOME NOT FOUND ON THE AIA-360 INSTRUMENT. CUSTOMER REPORTED THAT AFTER RUNNING THE BACKGROUND CHECK AND RUNNING TWO SAMPLES SUCCESSFULLY, THE ERROR OCCURRED ON THE THIRD SAMPLE. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES BHCG (BETA HUMAN CHORIONIC GONADOTROPIN), E2 (ESTRADIOL), PROG II (PROGESTERONE), LH II (LUTEINIZING HORMONE). ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BHCG, E2, PROG II, AND LH II. 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
    907673 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1