BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7403800 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-03734
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    May 9, 2016
    Report Date
    April 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WAS DISPATCHED. HE FOUND A REPORTING SOFTWARE COMPUTER FAILURE, ORDER NEW ALL IN ONE COMPUTER. ARRIVED ON 10-MAY-2016 AND CONFIRMED THE OLD COMPUER FAILURE. REMOVED THE HARD DRIVE FROM OLD COMPUTER AND GAVE IT TO MICHELLE / LAB TECH. THE NEW COMPUTER DIDN'T ARRIVED AT SITE ON 10-MAY-2016. ANOTHER FSE INSTALLED THE REPORTING SOFTWARE COMPUTER ON 11-MAY-2016 WHEN IT ARRIVED - INSTALLED REPLACEMENT ALL IN ONE PC PRELOADED WITH REPORTING SOFTWARE. VERIFIED SETTINGS ANF TRANMISSION OUTPUT VIA HYPER TERMINAL. CUSTOMER CALLED TO VERIFY SYSTEM WORKING AFTER VA BILOXI, THEIR IT SUPPORT, RESET THE INTERFACE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A COMPUTER FAILURE. THE SERIAL NUMBER OF THE G8 ANALYZER INSTALLED AT THIS ACCOUNT (12170703) WAS EXTRACTED FROM THE INSTALATION DATE OF THE DEVICE FILE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED THE DELL WON'T POWER UP WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED THAT THE ANALYZER WAS PLUGGED INTO AN UPS WITH OTHER THINGS THAT ARE WORKING. THEY DOESN'T HEAR THE DELL COME ON. PLUG INTO WALL. CHECK CABLES - DIFFICULT TO UNTANGLE SO DIDN'T GET THAT DONE. 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
    246741 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1