BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7356275 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-03533
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    April 1, 2016
    Report Date
    March 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ON 01-APRIL-2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE VERIFIED AND ADJUSTED THE NOZZLE, EKI BOARD, LEVEL SENSE, HAND TOUCH AND LEVEL SENSE BUT THE ERROR PERSISTED. THE FSE DETERMINED THAT THE PROBLEM WAS THE SAMPLER Z AXIS DRIVE ASSEMBLY. THE FSE REPLACED AND REALIGNED ALL NEEDED ALIGNMENTS THEN UPDATED THE SOFTWARE TO VERSION 2.51. ALL ERRORS CLEARED AND THE AIA-900 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR A TSH PRECISION ISSUE/LOW RECOVERY DURING PRECISION RUN WAS THE SPECIMEN Z DRIVE.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED A TSH PRECISION ISSUE/LOW RECOVERY DURING PRECISION RUN ON THE AIA-900 INSTRUMENT. TECHNICAL SUPPORT REQUESTED DATA FROM THE CUSTOMER AND FOUND THAT 1) THE INSTRUMENT WAS SHORT SAMPLING OR RAN OUT OF SAMPLE WITH NO ERROR FLAG OR 2) THE SUBSTRATE WAS NOT BEING DELIVERED. THE CUSTOMER STATED THAT THE CALIBRATION AND QUALITY CONTROL (QC) RESULTS WERE ACCEPTABLE WHEN THE SAMPLES WERE RUN. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON TSH. ON (B)(4) 2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR TSH. 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
    198037 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1