BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7322097 · Received March 7, 2018

    Report

    Report Number
    8031673-2018-01198
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    March 29, 2017
    Report Date
    March 7, 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. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(6). ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE FOUND THE DISPENSE LANE WAS INTERMITTENTLY OUT OF POSITION AT SORTER D LANE CUP PUT POSITION. THE FSE VERIFIED THE TIGHTNESS OF THE DISPENSE LANE MOUNTING SCREWS, MOTOR, AND SENSORS. THE D-LANE DRIVE BELT WAS LOOSE; THE FSE TIGHTENED THE DRIVE BELT. THE FSE VERIFIED THE SORTER TEST WITH FOUR FULL STD TRAYS. THE CUSTOMER RAN VITAMIN-D ASSAY. ALL ERRORS CLEARED AND THE AIA-900 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR ERROR 4053 SORTER-Z HOME OVERRUN WAS THE DISPENSE LANE DRIVE BELT WAS LOOSE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED ERROR 4053 SORTER-Z HOME OVERRUN ON THE AIA-900 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON ESTRADIOL (E2) AND HBA1C DIABETES MARKER. 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 HBA1C AND E2. 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
    163216 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1