BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7343246 · Received March 15, 2018

    Report

    Report Number
    3005529799-2018-03111
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    April 28, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    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 (B)(4). ON (B)(6) 2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THE FSE REPLACED THE WASH PROBE AND WASTE PUMP, THEN VERIFIED PROPER OPERATION. THE WASH, DILUENT, AND SAMPLE SYRINGE TIPS WERE REPLACED AND VERIFIED TO BE OPERATING PROPERLY. THE FSE RAN TT3 CALIBRATION, MAC CONTROL PERCISION WITHOUT ERRORS. THE CUSTOMER RAN T4 CALIBRATION AND RECEIVED A DETECTOR LOW (DL) ERROR. THE CUSTOMER REPLACED THE SUBSTRATE SOLUTION, PRIMED THE OLD SUBSTRATE OUT OF DEVICE AND RAN T4 CALIBRATION AND QC AGAIN WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE FAULT/FAILURE OF THE WASTE PUMP.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED POOR PRECISION AND LOW CONTROL ISSUES FOR FT4 AND T4 WITH THEIR A1A-360 ANALYZER. THE CUSTOMER ATTEMPTED DECONTAMINATION WITH 10% BLEACH, A NEW WASH PROBE TIP, AND FLUSHED WITH WASH AND DILUENT WITHOUT RESOLUTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING 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
    184411 AIA-360 AIA-360 KHO TOSOH BIOSCIENCE, INC. AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1