BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7382330 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-03712
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    November 28, 2016
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 REVIEWED FLAG CHART AND NO HB F FLAG WAS FOUND. ASSISTED THE CUSTOMER WITH INPUTTING THE 03=>22.0 IN THE G8. TS ANSWERED QUESTIONS AND ASSISTED WITH SETTING UP THE FLAG FOR USE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS NO FLAG FOR HB F WAS SET UP IN G8 ANALYZER.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED DISCREPANT PATIENT RESULT WITH THEIR HLC-723G8 ANALYZER. THE CUSTOMER REPORTED IT HAD A HA1C WITH A HB F OF 24.9%. THIS COMPLAINT WAS DEEMED TO BE REPORTABLE AND CLASSIFIED AS A LEVEL-2 EVENT DUE TO A DISCREPANT PATIENT RESULT. 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
    224484 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1