BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7341503 · Received March 15, 2018

    Report

    Report Number
    8031673-2018-02517
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    January 25, 2017
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (B)(4). TS (TECHNICAL SUPPORT) ADVISED TO DIFFERENT METHODOLOGIES USED, UNKNOWN IF QC (QUALITY CONTROL) WAS RUN ON THE 'FINGER STICK' DEVICE THAT DAY OR CALIBRATIONS, TOO MANY VARIABLES INVOLVED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS AN EVENTUAL DIFFERENT TESTING METHODS INVOLVED.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS WITH THEIR HLC-723G8 ANALYZER SN#(B)(4). CUSTOMER REPORTED THAT THEY HAD A PATIENT SAMPLE THAT WAS RUN ON THE G8 AND THEY GOT A 6.3 A1C RESULT, THEY ALSO HAD THIS SAME PATIENT BE RUN ON A MANUAL 'FINGER STICK' TYPE OF DEVICE AT ANOTHER OFFICE AND THE RESULT THERE WAS 6.7. THE DR IN THE OFFICE QUESTIONED THEM THAT THIS WAS TOO BIG OF A DIFFERENCE AND WANTED TO KNOW WHY THE TWO RESULTS DID NOT MATCH. 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
    187002 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1