BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7356458 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-02176
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    April 4, 2016
    Report Date
    March 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 04-APR-2016, THE FSE REPLACED THE UPPER PIB BOARD ON Z AXIS, RAN SEVERAL PATIENTS SAMPLES, AND VERIFIIED PROPER OPERATION. THE G8 WAS FUNCTIONING PROPERLY AND THE ERROR CLEARED. NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE PIB BOARD. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER CALLED TO REPORT THAT THEIR G8 ANALYZER HAS ONGOING Z1 ERRORS AND WOULD LIKE TO SPEAK WITH A ASKING TO SPEAK WITH A FIELD SERVICE ENGINEER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195089 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1