BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7098860 · Received December 7, 2017

    Report

    Report Number
    8031673-2017-00145
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 7, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    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) FOLLOWED-UP OVER-THE-PHONE AND INSTRUCTED THE CUSTOMER TO TURN THE AIA-360 INSTRUMENT OFF AND ROTATE THE TURN TABLE BY HAND AND THEN TURN THE INSTRUMENT BACK ON. THE CUSTOMER REPORTED THAT UPON START-UP THE AIA-360 WAS FUNCTIONING WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE THREE (3) SIMILAR COMPLAINTS REPORTED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES, INDICATES THAT 4004 TURN TABLE SLIP ERROR MESSAGE IS GENERATED WHEN THE TURN TABLE MOTOR HAS SLIPPED. THE OPERATOR IS INSTRUCTED TO TURN THE POWER OFF AND ON AGAIN. IF THIS PROBLEM REOCCURS, TO CONTACT THE SERVICE DEPARTMENT. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A FAULTY TURN TABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 4004 TURN TABLE SLIP ERROR MESSAGE WHILE RUNNING QUALITY CONTROLS ON THE AIA-360 INSTRUMENT. THE CUSTOMER REQUESTED SERVICE IN ORDER TO RESOLVE THE ISSUE. ON (B)(6) 2017 FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR LUTEINIZING HORMONE (LH II), ESTRADIOL (E2), PROGESTERONE (PROG), AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE WAS 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
    877250 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1