BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8095296 · Received November 21, 2018

    Report

    Report Number
    8031673-2018-00982
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 21, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE WAS ABLE TO REPRODUCE THE PROBLEM BY TURNING ON THE PUMP. FSE FOUND THAT THE LINE 6 WAS CLOGGED AND REPLACED THE TUBING FROM POSITION 6 ON THE INJECTOR VALVE TO THE BOTTOM OF THE PREFILTER ASSEMBLY. DECONTAMINATION COULD NOT BE PERFORMED DUE TO THE CLOGGED LINE 6. FSE THEN RAN QUALITY CONTROL (QC) WITH ACCEPTABLE RESULTS AND THE PRESSURE WAS STABLE AT 9.2 MP 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 (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE TWO (2) SIMILAR COMPLAINTS, INCLUDING THIS COMPLAINT, 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A CLOGGED IN THE PEEK TUBING BETWEEN THE I-6 ON THE INJECTOR VALVE AND THE BOTTOM OF THE PREFILTER ASSEMBLY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 100 PRESSURE HIGH ERROR MESSAGES WITH THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE COLUMN COUNT WAS 1182 INJECTIONS AND THE PRESSURE WAS 12.5 MPA. TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER TO REMOVE THE SCREW AND TUBING ABOVE THE PREFILTER AND PRESSURE DROPPED TO 4.5 MPA. THE CUSTOMER DID NOT HAVE A SPARE SAMPLE NEEDLE FOR REPLACEMENT. THE CUSTOMER REPORTED THAT THE EVENT HAS OCCURRED AT LEAST THREE TIMES. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH 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
    936702 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1