BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7883926 · Received September 17, 2018

    Report

    Report Number
    8031673-2018-00853
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE FOUND THE PEEK TUBING CLOGGED FROM THE INJECTION VALVE TO THE LINE FILTER. THE PEEK TUBING WAS STUCK AND HARD TO REMOVE FROM THE LINE FILTER. UPON REMOVING THE PEEK TUBING FROM THE LINE FILTER, PART OF THE FERULE TUBING BROKE OFF INSIDE THE HOUSING AND WAS UNABLE TO BE REMOVED FROM THE HOUSING. FSE REMOVED THE OBSTRUCTION FROM THE PEEK TUBING AND REPLACED THE FILTER HOUSING. CUSTOMER MADE CALIBRATORS AND RAN QUALITY CONTROLS WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 28-JUL-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. 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. 100 PRESSURE HIGH THE PUMP PRESSURE EXCEEDED THE UPPER LIMIT (15 MPA) SET IN THE PRES HIGH PARAMETERS. WHEN THE FILTER OR COLUMN REPLACEMENT PERIOD HAS BEEN EXCEEDED, FIRST REPLACE THE FILTER OR COLUMN. IF THE PRESSURE IS STILL HIGH, REMOVE THE INLET AND OUTLET FLOW LINE AROUND THE COLUMN AND FILTER, AND DETERMINE WHICH PART IS THE CAUSE OF THE HIGH PRESSURE. THEN, CONTACT A TECHNICAL SUPPORT REPRESENTATIVE. IF THE PRESSURE DISPLAYED ON THE SCREEN IS: (A) GREATER THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT + 4 MPA, THEN REPLACE THE FILTER. (B) LESS THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT, THEN PROCEED WITH PRIMING THE COLUMN. 150 GRAD SENSOR ERROR INDICATES THAT THE GRAD SENSOR ON THE PUMP MALFUNCTIONED. COUNTERMEASURE: CHECK THE GRAD SENSOR. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO CLOGGED PEEK TUBING.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 100 PRESSURE HIGH AND 150 GRAD SENSOR ERROR MESSAGES WITH THE G8 INSTRUMENT. THE CUSTOMER CHANGED THE COLUMN AND THE FILTER BUT AS THE INSTRUMENT WAS RESTARTED, THE ERRORS REOCCURRED. TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER TO REMOVE THE SCREW AND TUBING FROM THE TOP OF THE PREFILTER AND THEN TURN THE PUMP ON. HOWEVER, THE 150 GRAD SENSOR ERROR 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 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
    721045 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1