BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 7322932 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-01750
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    January 27, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO FOUND ERRATIC RETENTION TIMES CAUSING PEAKS ERRORS. FSE REPLACE INLET AND PURGE VALVES TO CORRECT PROBLEM, CUSTOMER RAN CALIBRATION AND CONTROLS. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO THE INLET CHECK VALVE. 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 THE FIELD SERVICE ENGINEER (FSE) REPORTED ERRATIC RESOLUTION TIMES CAUSING PEAKS OF UNKNOWN ORIGIN (POO PEAKS) 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
    169101 G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1