BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7391262 · Received April 2, 2018

    Report

    Report Number
    8031673-2018-03947
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    August 18, 2015
    Report Date
    April 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE 25TH OF AUGUST 2015 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE FOUND THE SMALL SYRINGE WAS WORN OUT AND WAS REPLACED. ALSO, THE FSE REPLACED THE SMALL LOOP AND REBUILT THE 6-WAY VALVE AND THE INJECTION VALVE. THE SAMPLE NEEDLE ON THE INSTRUMENT WAS BENT , FSE REPLACED IT AND VERIFIED ALIGNMENT. FSE PRIMED THE SYSTEM AND THE PRESSURE IS STABLE AT APPROXIMATELY 9.5 MPA. A CALIBRATION AND QUALITY CONTROL RUN WAS PERFORMED AND RESULTS WERE WITHIN RANGE. INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELASED. NO FURTHER ACTION IS REQUIRED BY THE FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO WORN SMALL SYRINGE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING 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 THE (B)(6) 2015 THE CUSTOMER REPORTED LOW TOTAL AREA ON CAPPED WHOLE BLOOD SAMPLES. CUSTOMER STATED THAT THE ISSUE STARTED AT THE END OF THE DAY THE DAY BEFORE AND THEY WERE ABLE TO RUN DILUTED SAMPLES BUT NOT CAPPED WHOLE BLOOD SAMPLES. THE CUSTOMER INDICATED TO THE TECHNICAL SUPPORT GROUP (TSG) THAT THEY CHECKED THE HEMOLYSIS AND WASH SOLUTION AND ITS HALF FULL, AND THERE WERE NO KINKED TUBINGS. TSG REQUESTED THE CUSTOMER TO CHANGE THE SAMPLE NEEDLE, REPOWER THE INSTRUMENT AND THEN RUN DILUTED, CAPPED AND UNCAPPED SAMPLES IN THE SAME RACK. ON A FOLLOW UP CALL THE CUSTOMER INDICATED THAT THE DILUTED SAMPLES DID NOT WORK DUE TO INCORRECT MANUAL DILUTION WHICH GAVE HER A TOTAL AREA OF ZERO. THE CAPPED AND UNCAPPED WHOLE BLOOD SAMPLES TOTAL AREA WERE ACCEPTABLE. CUSTOMER TO RESUME TESTING BY RUNNING THEIR STRECK CONTROLS AND RERUN. ON THE (B)(6) 2015 CUSTOMER REPORTED THAT THE DILUTED PATIENT SAMPLE TOTAL ARES IS ACCEPTABLE BUT THE SAMPLES IN TUBES ARE GIVING LOW TOTAL AREA. THE CHROMATOGRAMS WERE REVIEWED AND THEY LOOK NORMAL. PER THE TSG REQUEST THE CUSTOMER CHECKED THE WASTE LINE TO SEE IF THERE IS ANY WASTE BACKING UP AND NONE WERE NOTED. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR 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
    233612 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1