BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7594955 · Received June 12, 2018

    Report

    Report Number
    8031673-2018-00503
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 16, 2018
    Report Date
    July 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEVICE EVALUATION BY MANUFACTURER: THE TEST CUP READER WAS RECEIVED FOR EVALUATION ON 21-MAY-2018. FUNCTIONAL TESTING WAS PERFORMED ON THE COMPONENT AND THE ERROR 3139 ANALOG +15V LOW MESSAGE APPEARED IMMEDIATELY. THE ERROR WAS DUPLICATED. THE PART FAILED TESTING. EVALUATION CODES: RESULTS: 120 ELECTRICAL PROBLEM, CONCLUSION CODE: 13 DEVICE DIFFICULT TO OPERATE.

    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: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE VERIFIED THE ERROR 3139 (ANALOG +15 V LOW). FSE FOUND A BED TEST CUP READER AND REPLACED IT. THE INSTRUMENT THEN OPERATED WITHOUT ANY ERRORS. FSE RAN CALIBRATION, PRECISION AND QUALITY CONTROL (QC) WITHOUT ANY ERRORS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) 16-APR-2017 THROUGH AWARE DATE OF (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [3139] ANALOG +15 V LOW. CAUSE: ANALOG +15 V VOLTAGE LOW STATUS WAS DETECTED. SAMPLING WILL BE INTERRUPTED. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK THE ANALOG +15 V. THE MOST PROBABLE CAUSE OF ERROR 3139 WAS A BAD TEST CUP READER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 3139 (ANALOG+15 V LOW) WHILE RUNNING THE AIA-900 INSTRUMENT. WHEN THE CUSTOMER TRIED TO RUN THE INSTRUMENT AGAIN, THE ERROR OCCURRED. THE INSTRUMENT WOULD NOT RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF ESTRADIOL (E2), FOLLICLE-STIMULATING HORMONE (FSH), AND LUTEINIZING HORMONE (LHII) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436033 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention