BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8082035 · Received November 16, 2018

    Report

    Report Number
    8031673-2018-05232
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 1, 2018
    Report Date
    April 30, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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. THE INSTRUMENT SERVICE CENTER GROUP RECEIVED THE PART BUT IT WAS LOST. THEREFORE, FURTHER EVALUATION COULD NOT BE PERFORMED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    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 INFORMATION: CONCOMITANT MEDICAL PRODUCTS.

    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. H.3. DEVICE EVALUATION BY MANUFACTURER: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE FOUND THAT THE DISPENSING LANE X-AXIS HOME SENSOR WAS NOT FUNCTIONING. FSE REPLACED THE SENSOR AND PERFORMED ALL DISPENSE LANE ALIGNMENTS. FSE RAN THREE LEVELS OF QUALITY CONTROLS WITH ACCEPTABLE RESULTS. THE INSTRUMENT AND SORTER 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 NUMBER 10684005FROM 01-OCT-2017 THROUGH AWARE DATE 01-NOV-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: [4081] D.LANE-X HOME NOT DETECTED CAUSE: THE HOME SENSOR S030 FAILED TO BE ACTIVATED AFTER THE DISPENSING LANE MOVED TOWARD THE HOME POSITION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S030 AND PM030 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE ERROR 4081 D. LANE-X HOME NOT DETECTED ERROR MESSAGE WAS DUE TO A FAULTY DISPENSING LANE X-AXIS HOME DETECTION PIA BOARD.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 4081 D.LANE-X HOME NOT DETECTED ON THE AIA-900 INSTRUMENT. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF 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
    919108 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1