BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6990977 · Received October 31, 2017

    Report

    Report Number
    8031673-2017-00079
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 1, 2017
    Report Date
    May 17, 2019
    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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. CORRECTED DATA: F9 APPROXIMATE AGE OF DEVICE: 6 YEARS. H4 DEVICE MANUFACTURE DATE: 2011-MAR-01.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 02-OCT-2017 A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED EVENT UPON INSPECTION OF THE G8 INSTRUMENT. THE FSE FOUND A FAULTY DEGASSING UNIT AND SOLENOID VALVE 2 STICKING OUT. THE FSE REPLACED BOTH PARTS. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(4) 2016 THROUGH (B)(4) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 2 - PRE-INSTALLATION, STATES THAT THE DEGASSING UNIT REMOVES AIR BUBBLES IN THE PUMPED ELUTION BUFFER. THE VACUUM PUMP RUNS INTERMITTENTLY TO KEEP A CONSTANT VACUUM PRESSURE IN THE CHAMBER. CHAPTER 2 - ASSAY OPERATIONS, 3.1 ASSAY PRINCIPLES, INDICATES THAT EACH ELUTION BUFFER IS DEGASSED BY THE ON-LINE DEGASSERS AND SWITCHED BY THE SOLENOID VALVES AS PROGRAMMED, THEN DELIVERED BY THE PUMP TO THE COLUMN AFTER PASSING THROUGH AN INJECTION VALVE AND FILTER. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO FAULTY DEGASSING UNIT.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED LOW PRESSURE AND ELUTION BUFFER 2 RUNNING OUT WHEN BEING RECENTLY INSTALLED ON THE G8 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON HBA1C. ON 02-OCT-2017 A 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.

    Additional Manufacturer Narrative · 1

    (B)(4), PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770645 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1