BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7385992 · Received March 30, 2018

    Report

    Report Number
    8031673-2018-03732
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 27, 2017
    Report Date
    March 30, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. TS (TECHNICAL SUPPORT) DISCUSSED THE FLAG WITH TECH AND THEY SENT SAMPLE OUT FOR CONFIRMATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED GETTING A1C ABOVE LINEARITY WITH THEIR HLC-723G8 ANALYZER. THEY RERAN THE SAMPLE WITH THE SAME RESULT. LAB PROTOCOL SAYS THEY SEND OUT SAMPLES ABOVE LINEARITY FOR SA1CS - ABOVE 18, SO THEY ARE SENDING THE SAMPLE OUT. QC (QUALITY CONTROL) IS IN RANGE AND THIS IS THE ONLY SAMPLE ABOVE LINEARITY. THERE IS NO REASON TO SUSPECT THE ANALYZER IS AT FAULT - QC IN RANGE, CGRAMS LOOK NORMAL AND OTHER SAMPLES ARE NOT IN QUESTION. 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
    229804 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1