BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7149154 · Received December 27, 2017

    Report

    Report Number
    8031673-2017-00202
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 27, 2017
    Report Date
    October 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER: 019945. 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. CORRECTION: UPDATED CATALOG #.

    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. THE FSE CONFIRMED THE CUSTOMER'S COMPLAINT AND IDENTIFIED THE ISSUE TO BE A DEFECTIVE DISPLAY SCREEN. FSE REPLACED THE DISPLAY SCREEN UNIT AND PERFORMED SOFTWARE UPGRADE. FSE THEN RAN QUALITY CONTROLS (QC) AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS ON (B)(4) WAS PERFORMED FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL, UNDER SECTION 7-1: LIST OF ERROR MESSAGES INDICATES THAT FOR ISSUES INVOLVING COMMUNICATION-RELATED, CONTROL-RELATED, AND SYSTEM-RELATED ERRORS, THE SOLUTION FOR CUSTOMER IS TO TURN THE POWER OFF AND ON AGAIN. IF THIS PROBLEM RECURS, TO CONTACT THE SERVICE DEPARTMENT. THE MOSTLY LIKELY CAUSE IS DUE TO DEFECTIVE SCREEN DISPLAY.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED THE TOUCH FUNCTION ON THE DISPLAY SCREEN OF THE AIA-360 INSTRUMENT IS NOT RESPONDING TO INPUTS. CUSTOMER STATED REBOOTING AND CLEANING THE ANALYZER DID NOT HELP. SERVICE WAS REQUESTED. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FS) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES FOR ESTRADIOL (E2) AND FOLLICLE STIMULATING HORMONE (FSH). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927148 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1