BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7932495 · Received October 3, 2018

    Report

    Report Number
    8031673-2018-00895
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 3, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. FSE ARRIVED ON SITE TO ADDRESS THE REPORTED EVENT. FSE FIRST DUPLICATED THE ERROR; THEN, REPLACED THE INJECTION VALVE TO LINE FILTER TUBE AND PEEK SAMPLE LOOP. FSE WAS SUBSEQUENTLY ABLE TO RUN QUALITY CONTROL (QC) WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 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. 102 PRES LIMIT OVER THE PUMP PRESSURE HAS RISEN ABNORMALLY AND HAS CAUSED THE SHUTDOWN CIRCUIT TO BE ACTIVATED. TURN THE MAIN POWER SWITCH OFF AND REMOVE THE CAUSE OF THE PRESSURE INCREASE. REFER TO 100 PRESSURE HIGH. 150 GRAD SENSOR ERROR THE GRAD SENSOR ON THE PUMP HAS MALFUNCTIONED. THE OPERATOR IS INSTRUCTED TO CHECK THE GRAD SENSOR. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO FAILURE OF THE PEEK SAMPLE LOOP AND TUBING FOR INJECTION VALVE TO LINE FILTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE "150 GRAD PRESSURE" AND "102 PRES LIMIT OVER" ERRORS ON THEIR G8 ANALYZER. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT BY REBOOTING; HOWEVER, THE ERRORS PERSISTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE WAS 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
    771397 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1