BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7341935 · Received March 15, 2018

    Report

    Report Number
    8031673-2018-02721
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    June 4, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (B)(4). ON 06-JUN-2016, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE REPLACED THE ROTOR SEAL THEN RAN CONTROLS AND PRECISION. DEVICE OPERATION WAS VERIFIED AND NO FURTHER ERRORS WERE REPORTED. NO FURTHER ACTION WAS REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULT/ FAILURE OF THE ROTOR SEAL.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED "706 L SYRINGE ERROR" WITH THEIR G8 ANALYZER. THE CUSTOMER REPLACED THE SAMPLE PROBE AND PRIMED WITH THE LARGE SYRINGE CONNECTED; HOWEVER, THE ERROR PERSISTED. NEXT, THE CUSTOMER DISCONNECTED THE LARGE SYRINGE AND PRIMED AGAIN WITHOUT RESOLUTION. ON (B)(6) 2016, 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
    184601 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1