BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7325522 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-01839
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    April 11, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE. THE FSE SPOKE TO THE CUSTOMER ON THE PHONE AND THE CUSTOMER STATED THAT THE ROD ON THE Z AXIS WAS LUBRICATED, AT THE REQUEST OF THE TECHNICAL SERVICES GROUP, AND IT GOT MUCH QUIETER. THE G8 ANALYZER WAS UP AND OPERATIONAL AND ALL ERRORS CLEARED. THE G8 ANALYZER WAS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS THAT THE Z-AXIS ROD NEEDED LUBRICATION. A COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS CONDUCTED FROM 11-MAR-2015 THROUGH 11-APR-2016 FOR SIMILAR COMPLAINTS. THERE WERE NO SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCH PERIOD. TOSOH BIOSCIENCE, INC. IS SUBMITTNG 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 A CUSTOMER REPORTED A GRINDING NOISE WITH THE SAMPLE PROBE ON 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
    167525 TOSOH HLC-723G8 ANALYZER G8 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1