BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7

    MDR report key: 7376220 · Received March 27, 2018

    Report

    Report Number
    8031673-2018-03259
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    November 25, 2015
    Report Date
    March 27, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K011434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER WAS DISPATCHED ON 11/25/2015. THE FSE INSPECTED THE GRADIENT SENSOR. THE FSE FOUND THE PUMP PUMPING ERADICALLY, NOT ABLE TO MAKE ONE COMPLETE TURN. THE FSE REPLACED THE FLUID PUMPING UNIT, ADJUSTED FLOW, RAN CALIBRATORS, CONTROLS, AND PATIENTS. THE G7 ANALYZER WAS FUNCTIONING AS INTENDED AND ERRORS CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE PUMP UNIT A MECHANICAL FAILURE TOSOH BIOSCIENCE, INC. IS SUBMITTNG ON BEHALF OF THE FOREIGN MANUFACTURER TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT ISBEING 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) 2015 A CUSTOMER REPORTED GRAD (GRADIENT) SENSOR ERROR WITH THEIR G7 ANALYZER. 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
    215682 G7 G7 LCP TOSOH CORPORATION G7

    Patients

    Seq Age Sex Outcome Treatment
    1