BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7380507 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-04420
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    April 17, 2017
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. A FIELD SERVICE ENGINEER WAS DISPATCHED ON 4/17/2018. THE FSE REPLACED THE UPTAKE AND PURGE CHECK VALVES FOR THE PUMP AND RAN PRECISION AND RESULTS WERE WITHIN PRECISION SPECIFICATIONS. THE FSE WORKED ON THE PEEK TUBING FROM PRE-FILTER TO HEATER COIL STRESSED AND REPLACED IT. THE FSE REPORTED THE SAMPLE PROBE WORN AND GAVE REPLACEMENT. THE FSE RAN CALIBRATION AND CONTROLS AND CUSTOMER VERIFIED RESULTS WITHIN RANGE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE PURGE CHECK VALVE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED SPORADIC RETENTION TIMES WITH THEIR G8 ANALYZER. TECHNICAL SUPPORT ASKED THE CUSTOMER TO LOOK FOR ANY LEAKS BUT THERE WERE NONE. THE CUSTOMER THEN TRIED TO CHANGE THE FILTER COLUMN BUT THE ISSUE STILL DID NOT RESOLVE. 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
    219856 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| D