BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7397634 · Received April 4, 2018

    Report

    Report Number
    8031673-2018-04744
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    May 24, 2017
    Report Date
    April 4, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. 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: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 24 MAY 2017. THE CUSTOMER FURTHER REPORTED TO THE FSE DUE TO CONSTANT BF PURGE FAILURES THEY COULD NOT RUN PRECISION. THE ENGINEER FOUND THE TUBING FOR THE WASH PROBE NOT CONNECTED AND REINSTALLED THE TUBING. THE PUMP COUNT WAS NOTED TO BE OVER THE RECOMMENDED 20,000 TESTS SO THE ENGINEER REPLACED THE WASH, DILUENT AND WASTE PUMPS. THE FSE RAN PRECISION ON LOW LEVEL FT4 CONTROL AND QUALITY CONTROL (QC) FOR FT4 AND TSH. THE ENGINEER REPORTED THE PRECISION WITHIN SPECIFICATIONS AND QC WITHIN CUSTOMERS SET RANGES. THE ENGINEER RETURNED ON 31 MAY 2017 AND RAN START UP AND PRECISION ON LEVEL 1 AND 3 FOR FT4 AND REPORTED ALL WERE WITHIN SPECIFICATION. THE AIA 360 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS SUSPECTED TO BE A WEAK DILUENT PUMP

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED AFTER THEY'RE RUNNING FOR 3 TO 4 HRS FT4 WILL SUDDENLY RUN HIGH, WITH THEIR AIA 360 ANALYZER. UPON REPEAT THE CUSTOMER REPORTED THE RESULTS ARE NORMAL, THE CUSTOMER STATED THIS OCCURS WITH BOTH PATIENTS AND QUALITY CONTROL. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT DUE TO POTENTIAL DISCREPANT PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239116 AIA-360 AIA-360, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1