BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7403824 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-03745
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    February 24, 2016
    Report Date
    April 6, 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-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. FSE WAS DISPATCHED AND FOUND GROUNDING FROM NOZZLE LARGE NUT TO EKI BRD BEING INTERMITTENT WHEN NOZZLE MOUNTING WAS PRESSED ON. REMOVED EKI BRD. FILED MOUNTING STAND OFFS AND GROUNDING PADS TO MAKE BETTER CONNECTIONS. SWEATED SOLIDER CONNECTIONS ON EKI BRD , SCRAPPED AND TIGHTEN ALL GROUND SCREWS. WAS ABLE TO MEASURE ZERO OHMS CONSTANTLY THOUGH SAMPLER NOZZLE. ALSO REPLACED PIB S126. NO MORE LEVEL SENSE ERRORS. RAN CONTROLS AND THEY WERE OK. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS AN INTERMITTENT POOR GROUNDING IN SAMPLE SYSTEM.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED ERROR 2061 TIP DETACH FAILURE WITH THEIR AIA-2000 ANALYZER. CUSTOMER REPORTED THAT THEY TRY TO DETACH TIP AND FAILS. SOMETIME IT DROPS THE TIP AND PICKS UP A SECOND ONE AND CONTINUES. WHEN THEY CALLED THE 2000 WAS RUNNING BUT THEY'VE HAD THIS ERROR 3 OR 4 TIMES IN THAT DAY. WOULD LIKE FSE NOTIFIED. THE CUSTOMER IS UNABLE TO RUN BHCG FSH PROG LHII E2 AND PRL PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BHCG FSH PROG LHII E2 AND PRL 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
    247315 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1