BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7310965 · Received March 2, 2018

    Report

    Report Number
    8031673-2018-01636
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    March 24, 2016
    Report Date
    March 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER (FSE) PERFORMED VARIOUS SORTER ALIGNMENTS TO CORRECT PROBLEM WITH ERROR 4055 (SORTER Z-AXIS MOTOR SLIPPAGE DETECTED). THE FSE THEN VERIFIED THE INSTRUMENT WITH A MACRO CUP TRANSFER PROCEDURE AND TIP TRANSFER MOVEMENT EXERCISE.THE INSTRUMENT WAS PERFORMING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS IMPROPER ALIGNMENT OF THE SORTER. 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) 2016 A CUSTOMER REPORTED CUPS GETTING JAMMED IN THE SORTER OF THEIR AIA-2000 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN PTH PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF 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
    152497 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1