BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7385976 · Received March 30, 2018

    Report

    Report Number
    8031673-2018-03724
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    December 21, 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
    UT, 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 ON 22-DEC-2016 AND FOUND THAT CUSTOMER SWITCHED TO NEW CONTROLS AND LOW AREAS WENT AWAY. CUSTOMER NOT RECEIVING LOW AREAS ON CALIBRATORS OR PATIENT SAMPLES. FSE OPENED NEW TICKET FOR REQUESTED PM (PREVENTIVE MAINTENANCE). THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS FAULTY STRECK CONTROLS.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED LOW TOTAL AREA ON PATIENT RESULT WITH THEIR HLC-723G8 ANALYZER. THE CUSTOMER REPORTED THAT NO RESULTS ARE PRINTING, MESSAGE THAT RESULTS IS BELOW LINEARITY, LOW TOTAL AREA. CHANGED BUFFERS AND WASH/HEMO, NO AIR BUBBLES NOTED, WASTE TANK IS EMPTIED, PERFORMED A SAMPLE RESET, SAYS NEEDLE IS STRAIGHT, ALSO RUNS WITH THE CAPS OFF. BUFFERS ARE INSTALLED PROPERLY. ALL PATIENT CGRAMS MEETS ACCEPTANCE CRITERIA. THEY RAN NEW STREAK QC (QUALITY CONTROL) ARE NOW RUNNING AS EXPECTED. HIS INITIAL CALL WAS FROM HIS QC SPECIMENS ONLY. CUSTOMER REQUESTED A PM (PREVENTIVE MAINTENANCE) SCHEDULE. 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
    229627 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1