BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7750023 · Received August 5, 2018

    Report

    Report Number
    8031673-2018-00739
    Event Type
    Malfunction
    Date Received
    August 5, 2018
    Date of Event
    July 20, 2018
    Report Date
    December 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. FIRST, FSE CONFIRMED THE ERROR VIA THE ERROR LOG. INSPECTION OF THE DEVICE REVEALED THAT THE I-6 TUBING WAS CAUSING HIGH PRESSURE OF 16.50 MEGAPASCALS (MPA). FSE REPLACED THE I-6 TUBING AND PRESSURE RETURNED TO NORMAL AT 7.75 MPA. THE CUSTOMER 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). THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: THE 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. THE 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: GREATER THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT + 4 MPA, THEN REPLACE THE FILTER. LESS THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT, THEN PROCEED WITH PRIMING THE COLUMN. THE 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.

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED BY THE INSTRUMENT SERVICE CENTER (ISC) INDICATES THAT THE RETURNED INJECTION VALVE WAS MISPLACED BY ISC; THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO CLOGGED L6 TUBING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED "100 PRESSURE HIGH" AND "102 PRES LIMIT OVER" ERRORS ON THEIR G8 ANALYZER. THE CUSTOMER WAS UNABLE TO SILENCE THE ALARM UNTIL THE POWER WAS TURNED OFF. 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
    591377 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1