BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7364713 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-04214
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 28, 2017
    Report Date
    March 22, 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

    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. ON 29-MAR-2017, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FIRST, FSE VERIFIED THE HIGH PRESSURE. NEXT, HE REPLACED THE OBSTRUCTED PEEK TUBING. AFTERWARDS, PRESSURE WAS 9.9 MEGA PASCALS (MPA) WITH THE COLUMN AT 2700 INJECTIONS. FSE INSTALLED A NEWER COLUM AND THE PRESSURE DECREASED TO 8.55 MPA. NO FURTHER ISSUES WERE REPORTED AND NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A CLOG IN THE L-6 LINE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED RECEIVING HIGH PRESSURE WITH THEIR G8 ANALYZER. THE CUSTOMER REPLACED THE COLUMN AND FILTER WITH NO RESOLUTION. THE CUSTOMER ALSO PERFORMED A PRESSURE TEST ON THE DEVICE. ON (B)(4) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS 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
    206995 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1