BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7602884 · Received June 14, 2018

    Report

    Report Number
    8031673-2018-00544
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 14, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REPLACED THE FILTER BECAUSE IT HAS BEEN INSTALLED INCORRECTLY BY THE CUSTOMER. FSE THEN CHECKED THE PRESSURE AT THE RIGHT SIDE OF THE COLUMN WHICH READ 0.3 MP WITH THE OLD COLUMN PRESSURE READING OUT AT 12.31 MPA. FSE TRIED PLACING A NEW COLUMN AND GOT A PRESSURE OF 7.50 MPA. THE CUSTOMER ELECTED TO KEEP THE OLD COLUMN ON THE INSTRUMENT. THE G8 INSTRUMENT WAS WORKING AS DESIGNED. 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) AND COLUMN (SERIAL NUMBER (B)(4)) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND. 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: 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 MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A INCORRECTLY INSTALLED FILTER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ERROR 100 PRESSURE HIGH ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE PRESSURE WAS AT 10.8 MPA AND THEIR RANGE IS 10.6 MPA. THE INSTRUMENT WAS RUNNING NORMALLY WITH QUALITY CONTROLS IN RANGE AND NORMAL CHROMATOGRAMS. THE COLUMN COUNT (CC) WAS 930 (SERIAL NUMBER (B)(4)) AND THE FILTER COUNT (FC) WAS 6. THE FILTER WAS CHANGED PRIOR TO THE CALL BUT THE PRESSURE DID NOT CHANGE. TECHNICAL SUPPORT SPECIALISTS (TSS) REVIEWED CHROMATOGRAMS AND FOUND THE GLYCOSYLATED HEMOGLOBIN (SA1C) RETENTION TIME (RT) OF 0.62 MINUTES AND 0.61 MINUTES. TSS INSTRUCTED THE CUSTOMER TO CHANGE THE FLOW FACTOR (FF) FROM 1.04 ML/MIN TO 1.07 ML/MIN. THE CUSTOMER POWERED THE INSTRUMENT ON AND OFF AND CHECKED THE SA1C RT BY RUNNING PREVIOUSLY RUN PATIENT SAMPLES. FSE THEN RECALIBRATED AND RAN QUALITY CONTROLS. THE SA1C RT AFTER THE FF ADJUSTMENT WAS 0.59 MINUTES AND 0.60 MINUTES AND THE REPEAT PATIENT SAMPLES MATCHED THE PREVIOUS SA1C RESULTS. THE PRESSURE WITH THE NEW FILTER WAS 11.2 MPA. TSS REVIEWED THE COLUMN INSPECTION REPORT AND FOUND THAT THE STARTING PRESSURE WAS 7.6 MPA. DURING TROUBLESHOOTING, THE CUSTOMER REMOVED THE FILTER AND THE PRESSURE WAS 0.14 MPA. WHEN THE FILTER OUTLET WAS REMOVED, THE PRESSURE WAS 3.16 MPA. WHEN THE LEFT SIDE OF THE COLUMN WAS REMOVED, THE CUSTOMER OBTAINED HIGH PRESSURE ALARMS. WITH FURTHER EVALUATION, THE CC WAS 1148 AND TSS INSTRUCTED THE CUSTOMER TO REPLACE THE COLUMN. THE STARTING COLUMN PRESSURE WAS 6.6 MPA. THE TOTAL PRESSURE OF ALL COMPONENTS WAS 10.63 MPA. TSS ADVISED THE CUSTOMER TO REPLACE THE FILTER (FC=121). HOWEVER, AFTER REBOOT AT THE FLIP SWITCH, THE HIGH PRESSURE PERSISTED. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF HGA1C PATIENT RESULTS. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445759 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1