BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-360

    MDR report key: 7336982 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-02809
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 15, 2017
    Report Date
    March 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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) 2017, A FIELD SERVICE ENGINEER (FSE) CONDUCTED AN ONSITE FOLLOW-UP WITH THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, THE FSE FOUND THE SAMPLE NOZZLE BENT AND REPLACED IT. THEY CHECKED AND ADJUSTED ALL NOZZLE POSITIONS. THEY ALSO CHECKED AND ADJUSTED THE IMPASSE. THE INSTRUMENT WAS VERIFIED TO BE OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A BENT SAMPLE NOZZLE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED ERROR 2012 AIR DETACHED IN DILUENT AND ERROR 4020 SPEC Z AXIS HOME OVERRUN WITH THEIR AIA-360 ANALYZER. THE CUSTOMER REPOWERED THE INSTRUMENT SEVERAL TIMES WITH NO RESOLUTION. THEY TRIED CLEANING THE LEVEL SENSE PROBES AND CHECKING FOR FRAYED WIRES OR CRACKED CAPS WITHOUT ANY SUCCESS. ANY OTHER TROUBLESHOOTING STEPS THEY TOOK DID NOT RESOLVE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING TROPONIN AND CKMB CARDIAC ENZYMES 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
    179822 A1A-360 A1A-360 KHO TOSOH CORPORATION A1A-360

    Patients

    Seq Age Sex Outcome Treatment
    1