BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-360

    MDR report key: 7386527 · Received March 30, 2018

    Report

    Report Number
    3005529799-2018-04467
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    May 26, 2015
    Report Date
    March 30, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    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)(6) 2015, THE TSS ASKED THE CUSTOMER TO REBOOT THE AIA-360 AND THE DI LIS. THE CUSTOMER ATTEMPTED TO REBOOT THE AIA-360 AND DI THREE TIMES, BUT WAS UNABLE TO CONNECT TO THE LIS INTERFACE. THE CUSTOMER WAS THEN REFERRED TO THE LIS VENDOR FOR FURTHER ASSISTANCE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN INTERRUPTION OF COMMUNICATION WITH THE LIS.

    Description of Event or Problem · 0

    ON (B)(6) 2015 , A CUSTOMER REPORTED ERROR 1013 ASTM TIMEOUT ERROR. UNABLE TO RUN BHCG, E2 AND PROG SAMPLES. A TECHNICAL SUPPORT SPECIALIST (TSS) ASKED THE CUSTOMER TO REBOOT THE AIA-360 AND DATA INNOVATIONS (DI) LABORATORY INFORMATION SYSTEM (LIS). 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
    229828 A1A-360 A1A-360 KHO TOSOH BIOSCIENCE, INC. A1A-360

    Patients

    Seq Age Sex Outcome Treatment
    1