BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7324820 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-01951
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 21, 2017
    Report Date
    March 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2017 FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE FOR REPAIR/ INTERVENTION. THE FSE ADJUSTED THE SUBSTRATE SYRINGE SENSOR AND CLEANED & LUBRICATED THE SUBSTRATE SYRINGE. HE WAS ABLE TO PRIME THE SUBSTRATE AND PERFORM DAILY CHECKS WITHOUT ERRORS. THE CUSTOMER RAN CONTROLS AND VERIFIED THE RESULTS. NO FURTHER ACTION WAS REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS FAULT/FAILURE OF THE SUBSTRATE SYRINGE. 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 RECEIVING ERROR 2017 ON START UP, WITH THEIR AIA-360. SHE ATTEMPTED TO REBOOT WITH NO RESOLUTION . THE CUSTOMER DENIED SEEING AIR BUBBLES IN THE SUBSTRATE LINE AND REPOSITIONED THE LINE IN THE BOTTLE. SHE ALSO REMOVED THE BACK COVER AND NOTE THE B/F PROBE TUBING WAS ATTACHED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE REPORTED ISSUE WITH THEIR AIA-360 INSTRUMENT HAS THE POTENTIAL OF DELAY OF REPORTING PATIENT RESULTS FOR BHCG AND E2 WHICH WERE PURCHASED WITHIN 120 DAYS PRIOR TO AWARE DATE. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166801 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Death