BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7339531 · Received March 14, 2018

    Report

    Report Number
    8031673-2018-01875
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    January 11, 2017
    Report Date
    March 14, 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

    A FIELD SERVICE ENGINEER WAS DISPATCHED ON (B)(6) 2017. THE FSE REPLACED THE CHECK VALVES AND RAN PATIENT SAMPLES OVER 30 TIMES WITH NO MORE ERRORS. STRECK CONTROLS ARE IN. THERE IS NO FURTHER ACTION REQUIRED BY FIELD SERVICE. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE G8 ANALYZER WAS FUNCTIONING AS INTENDED WITH ALL ISSUES CLEARED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS MECHANICAL FAILURE OF PUMP. 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 (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED A0 PEAK WITH AN EXTRA HUMP AFTER THE A0 AND RETENTION TIMES ARE LONG WITH THE G8 ANALYZER. THE CUSTOMER IS UNABLE TO RUN HBAIC PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF HBAIC PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180857 TOSOH HLC-723G8 ANALYZER G8 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1