BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7448078 · Received April 20, 2018

    Report

    Report Number
    8031673-2018-00334
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 25, 2018
    Report Date
    April 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: A (B)(6) COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH AWARE DATE (B)(6) 2018. THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. 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 MOST PROBABLE CAUSE OF THE FAST RETENTION TIME WAS DUE TO THE FLOW FACTOR NEEDING ADJUSTMENT. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED SEEING FAST RETENTION TIME OF 0.62 MINUTES (ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES) ON A PATIENT SAMPLE WITH THE G8 INSTRUMENT. THE TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) ADVISED THE CUSTOMER TO ADJUST THE FLOW FACTOR FROM 1.07 ML/MIN TO 1.09 ML/MIN IN ORDER TO GET THE RETENTION TIME WITHIN ACCEPTABLE RANGE. THE CUSTOMER RE-BOOTED AND RECALIBRATED THE G8 INSTRUMENT AFTER ADJUSTING THE FLOW FACTOR AND THE PATIENT SAMPLE RETENTION TIME DECREASED TO 0.58 MINUTES. IT IS NOT KNOWN WHETHER HEMOGLOBIN A1C RESULTS WERE IMPACTED DUE TO THE OUT OF RANGE RETENTION TIME. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290798 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1