BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7001846 · Received November 3, 2017

    Report

    Report Number
    8031673-2017-00092
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 6, 2017
    Report Date
    December 29, 2017
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    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: ON 09-OCT-2017 A FIELD SERVICE ENGINEER (FSE) FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE AND CONFIRMED THE REPORTED EVENT. THE FSE HAD THE CUSTOMER REPLACED THE COLUMN, WHICH RESOLVED THE REPORTED HIGH PRESSURE ISSUE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 06-SEP-2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6 - TROUBLESHOOTING, STATES THE FOLLOWING: 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. THE OPERATOR IS ALSO INSTRUCTED TO INSPECT FOR CLOGGING AT FILTER AND COLUMN. CHAPTER 2 - PRE-INSTALLATION, STATES THE FOLLOWING: WHEN THE COLUMN IS NOT USED FOR MORE THAN ONE WEEK, REMOVE THE COLUMN FROM THE ANALYZER UNIT, REATTACH ITS PROTECTIVE PLUGS TO PROTECT IT FROM DRYING OUT AND STORE IN COOL DARK PLACE AT 4 TO 15 °C. - DO NOT BUMP OR SHAKE THE COLUMN. - ~6-9 MPA IS THE IDEAL PRESSURE, HOWEVER, EVERY INSTRUMENT IS SLIGHTLY DIFFERENT AND THE COMBINATION OF DIFFERENT COLUMNS WITH DIFFERENT INSTRUMENTS MAY SOMETIMES SHOW A SLIGHTLY HIGHER OR LOWER PRESSURE THAN THE IDEAL 6-9 MPA. SOME JUDGMENT MAY BE NECESSARY. ON THE COLUMN INSPECTION REPORT IS A PRESSURE SPECIFICATION, I.E., 5.1 MPA. 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE COLUMN.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 100 PRESSURE HIGH ERROR MESSAGES WHILE RUNNING PATIENT SAMPLES ON THE G8 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON HBA1C. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR 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
    778873 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1