BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7364709 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-04207
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 16, 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
    OR, 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. ON 17-MAR-2017, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE REPLACED THE SAMPLE LOOP, RAN WHOLE BLOOD, THEN QUALITY CONTROL (QC). NEXT, HE INSTRUCTED THE CUSTOMER TO RECALIBRATE AND RERUN CONTROLS. NO FURTHER ISSUES WERE REPORTED AND NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAULT/ FAILURE OF THE SAMPLE LOOP.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED HIGH PRESSURE WITH THEIR G8 ANALYZER. THEY CHANGED THE FILTER IN AN EFFORT TO TROUBLESHOOT BUT NOW THE DEVICE HAD NO PRESSURE. THE CUSTOMER, THEN ATTEMPTED A DRAIN FLUSH WITH NO RESOLUTION. AFTER INSPECTING THE DEVICE, HE FOUND THAT "THE SECOND VALVE DOWN WAS LEAKING". HE ATTEMPTED TO TIGHTEN THE TUBING BUT THE LEAK PERSISTED. ON (B)(4) 2017 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
    206972 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1