BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7349475 · Received March 19, 2018

    Report

    Report Number
    8031673-2018-02568
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    June 9, 2016
    Report Date
    March 19, 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-(B)(4). FSE WAS DISPATCHED AND ON 11-JUN-2016 CLEANED BARCODE READER AND VERIFIED PROPER OPERATION IN MAINTENANCE SOFTWARE. ENABLED OPTION M BARCODE SETTING. REPLACED COLUMN PER CUSTOMER REQUEST. RAN 20 SAMPLES TO VERIFY BARCODE READER WORKING PROPERLY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A DIRTY BARCODE READER.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED BARCODE ISSUE WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED ANALYZER WON'T READ ANY LABELS. 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
    192178 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1