BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7918195 · Received September 28, 2018

    Report

    Report Number
    8031673-2018-00881
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 7, 2018
    Report Date
    December 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DEVICE EVALUATION BY MANUFACTURER: THE UPTAKE CHECK VALVE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE PART USING WHOLE BLOOD SAMPLES AND THE RESULTS SHOWED EVIDENCE OF PROBLEMS WITH CHROMATOGRAPHY. THE RETENTION TIMES WERE FAST AND THERE WERE P00 PEAKS NOTED WITH AN UNSTABLE HEMOGLOBIN A1C RESULTS. THE REPORTED PRODUCT PROBLEM WAS CONFIRMED. EVALUATION CODES: RESULTS: 180 MECHANICAL PROBLEM IDENTIFIED. 13 DEVICE DIFFICULT TO OPERATE.

    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. DEVICE EVALUATION BY MANUFACTURER: THE SAMPLE NEEDLE ASSEMBLY WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A BEND IN THE NEEDLE AND A DEFORMED PIERCING TIP. THE REPORTED PRODUCT PROBLEM WAS CONFIRMED AND THE ERROR COULD BE DUPLICATED. THE PART FAILED VISUAL INSPECTION. EVALUATION CODES: METHOD: 10 TESTING OF ACTUAL/SUSPECTED DEVICE; 4109 HISTORICAL DATA ANALYSIS; RESULTS: 3211 DEFORMATION PROBLEM; CONCLUSION CODE: 4307 CAUSE TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO BENT SAMPLE NEEDLE WITH A DEFORMED PIERCING TIP, FAILURE OF THE UPTAKE VALVE, AND A BENT FINGER GUARD.

    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 ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING EVALUATION, THE FSE VERIFIED THE BENT SAMPLE NEEDLE AND ALSO NOTED TWO PATIENT SAMPLES TUBES THAT HAD BEEN PIERCED THROUGH THE SIDES. FSE REPLACED THE SAMPLE NEEDLE AND A BENT FINGER GUARD WHICH WAS LIKELY CAUSING THE BENT SAMPLE NEEDLE. DURING FURTHER TROUBLESHOOTING, FSE ALSO FOUND THAT THE RETENTION TIME (RT) WAS AT 0.63 MINUTES. FSE ADJUSTED THE FLOW FACTOR BUT THE RT WAS STILL FAST. FSE CHANGED THE UPTAKE CHECK VALVE ON THE PUMP AND ADJUSTED THE FLOW RATE FROM 1.08 ML/MIN TO 1.02 ML/MIN. THE RT THEN DROPPED TO 0.58 ML/MIN. QUALITY CONTROLS WERE PERFORMED AND HAD ACCEPTABLE RESULTS. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WAS ONE (1) SIMILAR COMPLAINT FOUND DURING THE SEARCHED PERIOD THE G8 OPERATOR'S MANUAL UNDER CHAPTER 5 MAINTENANCE PROCEDURES, 5.10 SAMPLING NEEDLE REPLACEMENT HAS A CAUTION THAT STATES THE FOLLOWING: REPLACE THE SAMPLING NEEDLE IF IT IS BENT OR BROKEN. USE THE FOLLOWING PROCEDURE TO REPLACE THE SAMPLING NEEDLE. ACCESS TO THE INSIDE OF THE ANALYZER IS NEEDED TO REPLACE THE SAMPLING NEEDLE. BE SURE THAT ONLY PERSONNEL WHO HAVE BEEN TRAINED BY (B)(4) OR ITS REPRESENTATIVES PERFORM THESE OPERATIONS. BE SURE TO WEAR PROTECTIVE CLOTHING (GOGGLES, GLOVES, MASK, ETC.) AND TAKE SUFFICIENT CARE TO PREVENT INFECTION DURING HANDLING. TAKE CARE NOT TO TOUCH THE END OF THE SAMPLING NEEDLE DURING HANDLING. IF THE NEEDLE PLACEMENT IS CLEARLY OFF CENTER OF THE PRIMARY TUBE, IT MUST BE ADJUSTED. CANCEL THE ASSAY AND CONTACT TECHNICAL SUPPORT. THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL UNDER LESSON 8 - TROUBLESHOOTING, STATES THE FOLLOWING: ADJUSTING THE FLOW RATE; HOW AND WHY ON THE (B)(4) 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 REPORTED EVENT HAS NOT YET BEEN DETERMINED. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SAMPLE PROBE WAS PIERCING THE CAP AND COMING OUTSIDE THE TUBE ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE QUALITY CONTROLS (QC) WERE IN BUT THEY WERE UNABLE TO RUN WITH CAPS AS THEY HAVE BEEN GETTING RESULTS OF ALL ZEROS. 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
    761408 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1