BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-360

    MDR report key: 7336981 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-02808
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 13, 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
    NY, 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 17-JAN-2017, A FIELD SERVICE ENGINEER (FSE) CONDUCTED AN ONSITE FOLLOW-UP TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE FOUND THAT THE IMPASSE TEST WAS SLIGHTLY OFF. FSE TRIED REPLACING THE SAMPLE NOZZLE AND RERAN THE SAMPLES BUT OBTAINED THE SAME RESULTS. THEY REPLACED THE SAMPLE NOZZLE WITH AN OLD NOZZLE AND RAN CHECKS ON IMPASSE VALUES. THE VOLTAGE FOR THE IMPASSE SENSOR WAS ADJUSTED AND WAS RAN 5 TIMES WITH SIMILAR RESULTS TO C-B. THE FINAL RESULT WAS NORMAL. THE FSE PERFORMED A SOFTWARE UPGRADE AND THE INSTRUMENT WAS VERIFIED TO BE OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS INCORRECT IMPASSE VOLTAGE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED ERROR 4017 CLOG DETECTED CLOG B PULSE 15 WITH THEIR AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT THE SAMPLE PROBE IS STILL INTACT BUT THEY ARE GETTING INTERMITTENT POUR OFF INTO TEST CUPS. THEY ARE UNABLE TO RUN PARATHYROID (PTH) PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING PTH 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
    179821 A1A-360 A1A-360 KHO TOSOH CORPORATION A1A-360

    Patients

    Seq Age Sex Outcome Treatment
    1