BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7334108 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-02453
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    March 20, 2017
    Report Date
    March 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 20-MARCH-2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE ADVISED THE CUSTOMER TO BACKFLUSH THE SAMPLE PROBE. THE FSE VISITED THE FACILITY AND ADJUSTED THE INSTRUMENT BUT THE RESULTS WERE STILL HIGH. HE THEN PERFORMED A PRECISION. ALL RESULTS WERE IN RANGE. THE AIA-900 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR THE SHBG CONTROL RECOVERY ISSUE WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED SHBG CONTROL RECOVERY ISSUE ON THE AIA-900 INSTRUMENT. THE CUSTOMER STATED THAT SHE HAD NOT TROUBLE WITH A LINEARITY PRECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177956 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1