BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7339414 · Received March 14, 2018

    Report

    Report Number
    8031673-2018-02492
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    April 11, 2017
    Report Date
    March 14, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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)(4). ON (B)(4) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THE FSE PERFORMED TROUBLESHOOTING AND FOUND A DEFECTIVE THERMISTOR ON THE P/D TABLE. THE FSE REPLACED THE THERMISTOR AND ADJUSTED THE TEMPERATURE. THE INSTRUMENT WAS THEN OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE A DEFECTIVE P/D TURNTABLE THERMISTOR.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED A P/D DETECTOR TABLE TEMPERATURE UNSTABLE WITH THEIR AIA-2000 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HGA1C 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
    181688 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1