BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7

    MDR report key: 7382309 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-03700
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    December 20, 2015
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K011434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. FSE WAS DISPATCHED AND ON 21-DEC-2015 FOUND THAT CUSTOMER REPORTED INJECTION VALVE ERROR, REPLACED SEALS IN INJECTION VALVE AND TIGTHEN ALLEN SCREWWS ON LEVER ARM ON MOTOR SHAFT. RAN CUST QC (QUALITY CONTROL), INSTRUMENT UP AND OPERATIONAL. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS AN ALLEN SCREW ON INJECTOR VALVE LEVER LOOSE.

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE CUSTOMER REPORTED INJECTION VALVE ERROR WITH THEIR HLC723G7 ANALYZER. CUSTOMER REPORTED INJECTION VALVE ERROR HAPPENED AFTER THE SECOND SAMPLE. ERROR CODE IS - 718 INJECTION VALVE ERROR WITH A GRINDING SOUND. RE-BOOTING THE ANALYZER DOES NOT HELP. THE SYSTEM WENT DOWN. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224062 G7 G7 LCP TOSOH CORPORATION G7

    Patients

    Seq Age Sex Outcome Treatment
    1