BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7106263 · Received December 11, 2017

    Report

    Report Number
    8031673-2017-00161
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 11, 2017
    Report Date
    August 3, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. FOR CORRECTED DATA, PLEASE REFER TO SECTIONS: D.4 UNIQUE IDENTIFIER (UDI) #. H.3. DEVICE EVALUATED BY MANUFACTURER. H.6. EVENT PROBLEM AND EVALUATION CODES.

    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: THE G8, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 21-FEB-2017 THROUGH 11-NOV-2017. THERE WERE NO OTHER COMPLAINTS IDENTIFIED 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. CHAPTER 5 - MAINTENANCE PROCEDURES, SECTION 5.6 PROVIDES STEP-BY-STEP INSTRUCTIONS ON COLUMN REPLACEMENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY COLUMN.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED SEEING FAST RETENTION TIMES OF 0.64 MINUTES (ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES) AND MISSING PEAKS ON THREE (3) PATIENT SAMPLES FOR HEMOGLOBIN A1C (HBA1C) WITH THE G8 INSTRUMENT. QUALITY CONTROLS (QC) WERE STILL WITHIN RANGE, BUT ALSO HAD FAST RETENTION TIME OF 0.64 MINUTES. PATIENT SAMPLES WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT COLUMN COUNT WAS AT1028 INJECTIONS (2500 MAXIMUM RECOMMENDED). THE CUSTOMER WAS INSTRUCTED TO ADJUST THE FLOW FACTOR; HOWEVER, QUALITY CONTROLS AND PATIENT SAMPLES CONTINUED TO HAVE FAST RETENTION TIMES OF 0.64. THE TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE COLUMN. ON 13-NOV-2017 THE CUSTOMER CONFIRMED THAT AFTER REPLACING THE COLUMN THE RETENTION TIME WAS 0.59 MINUTES. 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
    885835 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1