BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7342954 · Received March 15, 2018

    Report

    Report Number
    8031673-2018-01693
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    May 18, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, A FIELD SERVICE ENGINEER (FSE) CONDUCTED ON-SITE FOLLOW-UP WITH THE CUSTOMER. THE SAMPLE NEEDLE AND SYRINGE TIP WERE REPLACED. THE STATOR AND INYECTOR VALVE PARTS WERE CLEANED. IN ADDITION, THE FSE UPGRADED SOFTWARE TO LATEST VER. 5.23, ENABLED BARCODE OPTION M. HE THEN PRIMED THE INSTRUMENT AND RAN QUALITY CONTROLS (QC) WITH SATISFACTORY RESULTS. SINCE THE INSTRUMENT WAS FUNCTIONING AS INTENDED, NO ADDITIONAL ACTIVITIES BY FIELD SERVICE WERE REQUIRED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE LARGE SYRINGE AND SAMPLE NEEDLE. 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(B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED LOW TOTAL AREA ON THEIR FIRST SAMPLE IN THE RACK ON THEIR G8. THE CUSTOMER WAS UNABLE TO REPORT HBA1C PATIENT SAMPLES IN THAT POSITION. 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
    184684 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1