BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7364721 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-04223
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    May 1, 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 04-MAY-2017, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE REPLACED THE SAMPLE LOOP, ROTOR SEAL, AND STATOR FACE. THEN HE CLEANED & LUBRICATED THE SMALL AND LARGE SYRINGE ASSEMBLIES, FLUSHED ALL TUBINGS AND THE SAMPLE NEEDLE. THE SAMPLE NEEDLE WAS ALSO REALIGNED. FSE RAN QUALITY CONTROL (QC) AND CALIBRATION ON BOTH ANALYZERS AND TOTAL AREAS WERE NORMAL. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS FAULT/ FAILURE OF THE LARGE SYRINGE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED RECEIVING LOW TOTAL AREAS WITH SAMPLES ON THEIR G8 ANALYZER. THE CUSTOMER STATED THAT THEY CHANGED THE SAMPLE NEEDLE WITH NO RESOLUTION. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207075 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1