BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7363544 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03643
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    April 13, 2017
    Report Date
    March 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. FSE WAS DISPATCHED AND ON 20-APR-2017 CHECKED FOR LEAKS AND LOOSE CONNECTIONS. DECONTAMINATED INSTRUMENT. RAN PATIENT SAMPLE AFTER DECONTAMINATION 14 TIMES. ISSUE SEEN WITH MAS (MICROGENICS/THERMOFISHER) CONTROLS. CUSTOMER HAD NO OTHER CONTROLS. RAN TOSOH CALIBRATORS AS PATIENT SAMPLES. RESULTS SAME AS CALIBRATOR. RAN L1 AND L2 BR LINEARITY WHICH WAS ON THE MARK. SUSPECT MAS CONTROLS. CUSTOMER WAS HAPPY WITH PATIENT SAMPLES AND PRECISION. INSTRUMENT IS RUNNING WITH NO ISSUES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A POSSIBLE FAULTY MAS (MICROGENICS/THERMOFISHER) CONTROLS.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED RAN OUT OF HW BUFFER WITH THEIR HLC-723G8 ANALYZER. CGRAMS DON'T LOOK RIGHT. THEY MAY HAVE AIR IN THE LINES SO HAD HIM DO A DRAIN FLUSH THEN RERUN SAMPLES. ON (B)(6) 2017 CUSTOMER REPORTED THAT CGRAMS STILL DISPLAY EITHER A DELINEATED AND NON-DELINEATED PEAK AFTER THE AO. LAST WEEK THE BUFFERS WERE REPLACED AND STILL NO RESOLVE WITH THE CGRAMS. 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
    205734 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1