BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8177362 · Received December 18, 2018

    Report

    Report Number
    8031673-2018-05335
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 23, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE WAS INFORMED THAT THE PRINTER STARTED WORKING AFTER BEING CLEANED WITH COMPRESSED AIR. FSE VERIFIED THE PRINTER WAS OPERATIONAL BY PRINTING A CHROMATOGRAM. THE PRINTER WAS OPERATING AS EXPECTED. NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 23-OCT-2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THIS TIME. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING STATES THE FOLLOWING: 6.3 ERROR MESSAGES: WHEN CONSULTING WITH TECHNICAL SUPPORT ABOUT A PROBLEM, PLEASE NOTE THE ERROR MESSAGE AND ERROR NUMBER. IN ADDITION, IF YOU FOLLOW THE SUGGESTED SOLUTIONS IN THIS SECTION AND ARE STILL UNABLE TO RESOLVE THE ERROR, OR IF YOU ENCOUNTER AN ERROR MESSAGE THAT IS NOT NOTED, CONTACT TECHNICAL SUPPORT. GENERAL ERROR MESSAGES. WITH THESE ERRORS, THE ASSAY STOPS AND THE ANALYZER IMMEDIATELY ENTERS STAND-BY STATE. 401 PRINTER OFF LINE. THE PRINTER PAPER HOLDING LEVER IS LIFTED UP. SET THE LEVER CORRECTLY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE PRINTER BEGAN WORKING AFTER CLEANING IT COMPRESSED AIR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING A 401 PRINTER OFF LINE ERROR MESSAGE AFTER CHANGING THE PAPER ON THE G8 INSTRUMENT. THE CUSTOMER TRIED TO REINSTALL THE PAPER AND MOVED RELEASE LEVER TO THE CORRECT POSITION AND POWERED THE INSTRUMENT OFF AND ON. THE PROBLEM PERSISTED. THE CUSTOMER STOPPED USING THE INSTRUMENT FOR THE DAY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH COULD HAVE RESULTED IN DELAY OF RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016609 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1