BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7340041 · Received March 14, 2018

    Report

    Report Number
    8031673-2018-02714
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    January 28, 2016
    Report Date
    March 14, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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). ON 29-JAN-2016, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. INSPECTION/ TESTING OF THE DEVICE FOUND THAT PATIENT RESULTS WERE RETURNING WITH "HEMOGLOBIN VARIANT (HB-VAR) DETECT" ERRORS. FSE RAN SEVERAL SAMPLES, PRIMED THE DEVICE, AND ENABLED "OPTION M". HE ALSO INTERFACED THE ANALYZER TO THE LABORATORY INFORMATION SYSTEM (LIS) AND RETESTED. THE CUSTOMER WAS SUBSEQUENTLY, ABLE TO CALIBRATE AND RUN QUALITY CONTROL (QC) WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. OF NOTE, THE DEVICE HAD NOT BEEN IN USE FOR TWENTY-FIVE DAYS PRIOR TO THE REPORTED EVENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO COMMUNICATION ISSUES WITH INSTRUMENT INTERFACE SETTINGS.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED CALIBRATION ERRORS AND LOW TOTAL AREAS ON PATIENT SAMPLES WITH THEIR G8 ANALYZER. THE CUSTOMER STATED THAT THERE WERE NO OBVIOUS LEAKS AND THE DEVICE PRESSURES WERE NORMAL. ON (B)(6) 2016, 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
    181718 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1