BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7319832 · Received March 7, 2018

    Report

    Report Number
    8031673-2018-01457
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    April 12, 2016
    Report Date
    March 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(4). TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2016. THE FSE INSPECTED THE SYSTEM AND FOUND NO PEAK DETECTED MESSAGES. THE ENGINEER REMOVED THE COVERS, PERFORMED DRAIN FLUSH, AND E-PRIME OF THE SYSTEM. AIR WAS NOTED INSIDE THE SAMPLE SYRINGE UPON CHECKING THE SINKER IN HEMOLYSIS WASH AIR WAS FOUND TO BE BEING PULLED INTO THE HEMOLYSIS WASH INLET TUBING. THE FSE PERFORMED SAMPLE RESETS, REPEATED THE DRAIN FLUSH, AND REPLACED THE HEMOLYSIS WASH WITH A NEW RESERVOIR (CHANGE REAGENT RESET ACCORDINGLY). THE ENGINEER ALSO CHECKED THE DEPTH OF EACH BUFFER RESERVOIR TUBING LENGTH (SO TUBINGS CANNOT CURL UPWARD FROM BOTTOM OF BUFFER RESERVOIRS). FSE RAN TWENTY PATIENT SAMPLES WITH PRECISION ACCEPTABLE. AT THE CUSTOMERS REQUEST THE SYSTEM WAS RECALIBRATED. PRECISION, CALIBRATION & CONTROLS WERE ALL PERFORMING TO SPECIFICATION AND THE FSE RAN MORE PATIENT SAMPLES WITH CUSTOMER TO CONFIRM. THE G8 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO AIR IN SAMPLE SYRINGE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED A CUSTOMER REPORTED MISSING PEAKS WITH THEIR G8 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162692 TOSOH HLC-723G8 ANALYZER G8 G8, PRODUCT CODE: LCP LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1