BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 7377774 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-03429
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 8, 2017
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER WAS DISPATCHED WHO REPLACED THE SAMPLE Z AXIS ASSEMBLY AND PERFORMED A PRECISION CHECK.NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS PN XP035. 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) 2017 A CUSTOMER REPORTED Z AXIS ASSEMBLY ISSUE WITH THEIR G8 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2017 TO ADDRESS THE REPORTED EVENT,WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS HBA1C. 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
    222979 G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1