BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7381993 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-03275
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    August 24, 2015
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 08/24/2015. THE FSE ON 8/25/2017 F OUND THAT THE ANALYZER HAS OVER 20,000 INJECTIONS ON IT SINCE LAST PM (PREVENTATIVE MAINTENANCE). PERFORMED THE PM TO CORRECT THE QC (QUALITY CONTROL) SHIFT. AFTER COMPLETION OF THE PM, QC IS STILL AT THE HIGH END OF THE RANGE. THE FSE RECOMMEND TO THE CUSTOMER TO EITHER REPLACE THE COLUMN OR ORDER A NEW LOT OF CONTROLS, BUFFERS AND WASH. THE FSE ALSO FOUND THAT THE RUBBER O RINGS FOR THE SAMPLE NEEDLE IN THE KIT WERE SWOLLEN AND REPLACTED IT. THE CUSTOMER ALSO MENTIONED HAVING INTERMITTENT Z AXIS HOME ERRORS. THE FSE FOUND THAT THE SAMPLER Z CABLE AND SENSORS ARE BAD AND REPLACED AND ALIGNED. THE FSE NOTED THE SMALL SYRINGE IS WORN, AND REPLACED AND PRIMED. THE NEEDLE IS BENT, REPLACED WITH CUSTOMER STOCK. THE FSE FOUND 2 LARGE PAPERCLIPS, PIECES OF PAPER AND A LARGE COTTON TIPPED APPLICATOR INSIDE OF THE LOADER ASSEMBLY. RECOMMEND TO THE CUSTOMER THAT THESE NOT BE USED IN A WAY THAT THEY CAN FALL INTO THE LOADER. ON 8/26/2015 DURING FOLLOW-UP AFTER THE MORNING RUN, THE CUSTOMEER STATED GETTING INTERMITTENT HIGH AREA ERRORS. THE FSE WENT BACK ONSITE AND REPLACED THE LARGE SYRINGE AND REBUILT THE 6-WAY VALVE AND THE INJECTION VALVE. THE FSE INFORMED THE CUSTOMER THAT THE WASH THAT IS ONBOARD WAS PUT ON THE ANALYZER AROUND THE SAME DATE THAT THERE WAS A QC SHIFT. THE COLUMN AT THE TIME HAD VERY HIGH INJECTIONS ALSO.THE FSE TOOK A BOTTLE OF WASH WITH A NEWER RECEIVED DATE ON IT AND PLACED ON THE ANALYZER AND PRIMED THE SYSTEM, AND PRESSURE WAS GOOD. CALIBRATED AND RAN CONTROLS AGAIN. THE FSE REPLACED THE STOCK SAMPLE NEEDLE WITH A NEW NEEDLE . THE CUSTOMER WILL CONTINUE TO MONITOR AND CALL BACK THE TSS (TECHINAL SUPPORT SPECIALIST) GROUP IF THERE ARE FURTHER ISSUES. THE FSE UPGRADED THE SOFTWARE VERSION TO 5.20. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE G8 ANALYZER WAS FUNCTIONING AS INTENDED WITH ALL ISSUES CLEARED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE FAILURE OF THE PEEK TUBING . TOSOH BIOSCIENCE, INC. IS SUBMITTNG ON BEHALF OF THE FOREIGN MANUFACTURER TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT ISBEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2015 A CUSTOMER REPORTED QC TRENDING HIGHER WITH THE G8 ANALYZER. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224664 TOSOH HLC-723G8 ANALYZER G8 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1