BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7363532 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03638
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    April 3, 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
    NC, 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 04-APR-2017 TRIED TO DUPLICATE ISSUE BY RUNNING PUMP AND OPENING AND CLOSING VALVES. RAN TEST SAMPLE 20 TIMES. LOW PRESSURE HAPPENED ONCE. POSSIBLY SV3 SOLENOID VALVE FAILURE. REPLACED SV3 VALVE. RAN TEST SAMPLE WITH NO ERRORS. CUSTOMER RAN 40 TEST SAMPLES WITH NO ERRORS. INSTRUMENT IS RUNNING PER SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A SV3 SOLENOID VALVE FAILURE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED LOW PRESSURE WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED VERIFIED ALL BUFFER BAGS ARE FULL. NO LEAKS ARE PRESENT. BLED AIR FROM SYSTEM AND RUN PUMP, FOUND THAT WHEN SV-3 IS ENABLED PRESSURE IMMEDIATELY DROPS TO ZERO. REMOVED BUFFER BAG STRAW FILTER, WITH NO RESULTS. 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
    205863 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1