BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7353177 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-02587
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    September 19, 2016
    Report Date
    March 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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). CLINICAL SUPPORT SPECIALIST WENT ON SITE AND FOUND THE PIN SETTINGS FOR THE CONNECTOR WERE INCORRECT. PINS #2 AND #3 WERE CROSSED. HE MADE A NEW CONNECTOR WITH PINS #2 AND # 3 IN THE CORRECT SPOT AND DATA CROSSED SUCCESSFULLY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DATA NOT CROSSING TO LIS (LABORATORY INFORMATION SYSTEM) DUE TO INCORRECT PINOUT SETTINGS ON THE CONNECTOR.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED DATA NOT CROSSING FROM RPS (REPORTING SOFTWARE) TO LIS (LABORATORY INFORMATION SYSTEM) WITH THEIR HLC-723G8 ANALYZER. 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
    199237 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1