BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723GA ANALYZER G8

    MDR report key: 7360813 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03542
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    October 15, 2015
    Report Date
    March 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO CONTACT STRECK. ALL OTHER CHROMATOGRAMS WERE NORMAL. THE G8 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR HV3 ON THE L1 HAD HIGH RETENTION TIME ON THE STRECK QUALITY CONTROL WAS DEGRADED CONTROL MATERIAL.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED THAT HV3 ON THE L1 HAD HIGH RETENTION TIME ON THE STRECK QUALITY CONTROL ON THE G8 INSTRUMENT. THE CUSTOMER STATED THERE WAS NO FLAG ON THE LT. THE CUSTOMER RAN PATIENT SAMPLES AND NO FLAGS APPEARED. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO RUN CALIBRATION AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204193 TOSOH HLC-723GA ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1