BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7366715 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-03654
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    December 20, 2016
    Report Date
    March 23, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. FSE (FIELD SERVICE ENGINEER) PHONE CALLED THE CUSTOMER AND ORDERED FOR DELIVERY ON 21-DEC-2016 A NEW SAMPLE LOOP. EXPLAINED TO CUSTOMER HOW TO DO, ADVISED IF NEEDED TO CALL TECH SUPPORT AND THEY WILL HAVE SOMEONE PHONE ASSIST. ON 21-DEC-2016 THE FSE WORKED WITH THE CUSTOMER ON THE PHONE AND WALKED THE CUSTOMER THROUGH REPLACING SAMPLE LOOP. CUSTOMER RECALIBRATED AND RAN QC (QUALITY CONTROL). ALL LEVELS WENT BACK DOWN TO MEAN OF QC RANGE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A PARTIALLY CLOGGED SAMPLE LOOP.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED CONTROL RUNNING HIGH WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED HIGH SA1C RT (RETENTION TIME), RECALIBRATED AND PUT ON A NEW CONTROL BUT THE CONTROL RECOVERY DID NOT COME DOWN. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. 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
    209694 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1