BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 7323486 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-01754
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    March 14, 2016
    Report Date
    March 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO UPGRADED THE SOFTWARE TO 5.23 FOR BARCODE READ ISSUES, ENABLED OPTION M, TESTED UNIT AND RAN THREE RACKS OF TEN WITH NO READ ERRORS. NO FURTHER ACTION REQUIRED BY FSE THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO THE SOFTWARE. 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 BARCODE ISSUES WITH THEIR G8 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2016 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
    168570 G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1