BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7988245 · Received October 20, 2018

    Report

    Report Number
    8031673-2018-00708
    Event Type
    Malfunction
    Date Received
    October 20, 2018
    Date of Event
    October 8, 2018
    Report Date
    December 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4) IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, (B)(4), PER EXEMPTION NUMBER E2017013. IT WAS NOTED IN FOLLOW UP #1 IN SECTION D10 THAT A PART WAS RETURNED ON (B)(6) 2018. HOWEVER, THE PART IS NO LONGER AVAILABLE AS IT HAS BEEN LOST. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    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. FSE PERFORMED THE REPAIR ALONG WITH A PREVENTATIVE MAINTENANCE (PM). DURING SERVICING, FSE REPLACED THE PUMP UNIT AND THEN RAN QUALITY CONTROLS (QC) WITH ACCEPTABLE RESULTS. THE G8 INSTRUMENT WAS WORKING AS EXPECTED. NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 08-SEPT-2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE 3 SIMILAR COMPLAINTS, INCLUDING THIS COMPLAINT, FOUND DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL UNDER LESSON 8 - TROUBLESHOOTING, STATES THE FOLLOWING: ADJUSTING THE FLOW RATE - HOW AND WHY: ON THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8; VARIANT ANALYSIS MODE IT MAY BE NECESSARY TO ADJUST THE FLOW RATE BECAUSE EITHER UNIDENTIFIABLE PEAKS APPEAR ON ALL THE CHROMATOGRAMS OR THE AVERAGE RETENTION TIME FOR VARIOUS PEAKS HAS CHANGED SIGNIFICANTLY. THE FLOW RATE IS CHANGED BY CHANGING THE FLOW FACTOR IN THE INSTRUMENT. THE FLOW FACTOR IS GENERALLY 1.00 ML/MIN. THE FLOW FACTOR SHOULD ONLY BE ADJUSTED +/- 0.05 OF THE DEFAULT FACTORY SETTING. 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. 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 MALFUNCTIONED. CHECK THE GRAD SENSOR. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAILURE OF THE PUMP UNIT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING INTERMITTENT 102 PRESSURE OVER LIMIT AND 105 GRAD SENSOR ERROR MESSAGES WITH THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE RETENTION TIME WAS ALSO FLUCTUATING. 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
    828622 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1