BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7364706 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-04205
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 11, 2017
    Report Date
    March 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ON 13-MAR-2017, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. HE REPLACED THE L-6 LINE PEEK TUBING AND INSPECTED THE INJECTION VALVE. PRESSURE WAS NOW NORMAL AT APPROXIMATELY 8.30 MEGA PASCALS (MPA) AND QUALITY CONTROL (QC) SUBSEQUENTLY RAN WITHOUT ERROR. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN L-6 LINE OBSTRUCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED RECEIVING HIGH PRESSURE ALARMS WITH THEIR G8 ANALYZER. THE CUSTOMER STATED THAT SHE REPLACED THE COLUMN, FILTER, CHECKED THE FITTING, THEN REBOOTED, BUT THE ALARMS PERSISTED. ADDITIONALLY, SHE PERFORMED PRESSURE TESTS AND REMOVED THE WING NUT WITH NO RESOLUTION. ON (B)(6) 2017 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
    207101 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1