BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7311967 · Received March 2, 2018

    Report

    Report Number
    8031673-2018-01935
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    April 10, 2017
    Report Date
    March 2, 2018
    Manufacturer
    TOSOH CORPORATION
    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

    CUSTOMER REPOWERED AIA-360 AND PAPER FEED IS NOW WORKING. INSTALLED TOSOH PRINTER PAPER. PRINTER ROLLERS ARE MOVING BUT WHEN HE ATTEMPTS TO REPRINT DAILY CHECK, THE REPORT WILL NOT PRINT. FSE WAS DISPATCHED BY TECHNICAL SUPPORT. FSE ATTEMPTED TO CALL THE ACCOUNT ON (B)(6) 2017 AND ACCOUNT DID NOT ANSWER ANY CONTACT ATTEMPTS. SERVICE REPORT WAS CLOSED WITH NO RESOLUTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS PRINTER FAILURE - ACCOUNT DID NOT ANSWER ANY CONTACT ATTEMPTS. 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).

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED PRINTER NOT WORKING WITH THEIR AIA-360 ANALYZER SN#(B)(4). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED BY TECHNICAL SUPPORT. THE REPORTED ISSUE WITH THEIR AIA-360 INSTRUMENT HAS THE POTENTIAL FOR CAUSING A DELAY IN REPORTING OF PATIENT RESULTS FOR BHCG ASSAY. 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
    154620 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1