BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7385941 · Received March 30, 2018

    Report

    Report Number
    8031673-2018-03720
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    August 12, 2016
    Report Date
    March 30, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 PHONE CALLED ON 15-AUG-2016 ASSISTING CUSTOMER IN ATTEMPT TO RESOLVE THE PROBLEM. ON 17-AUG-2016 FSE WAS DISPATCHED AND WHILE ON SITE, HE CORRECTED THE PROBLEM BY PUTTING BACK SOME REPLACED PARTS IN TROUBLESHOOTING, SOME REMAINED AND SOME PARTS LEFT ON SITE. RESOLUTION OF PROBLEM WAS THAT BUFFER 1 AND 2 WERE ACCIDENTLY REVERSED. FSE WAS DISPATCHED AND ON 30-MAR-2016 REMOVED SAMPLE LOADER COVER AND REMOVED A SAMPLE CUP CAUSING THE ERROR. ALSO CLEANED OUT THE ENTIRE SAMPLE LOADER AND UPGRADED THE SOFTWARE TO 5.23. INSTRUMENT RAN FINE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WERE REVERSED BUFFER 1 AND 2.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED ERRORS 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
    228932 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1