BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7383859 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-03284
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    September 24, 2015
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER WAS DISPATCHED ON 09/24/2015 THE FIELD SERVICE ENGINEER ( FSE) PHONED THE CUSTOMER AND HAD THE CUSTOMER HOLD ON TO PEEK TUBING AND TWIST THE FERRULE UNTIL IT RELEASES FROM PEEK TUBING TO CORRECT ISSUE. INSTRUMENT IS FINE, NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE G8 ANALYZER IS FUNCTIONING AS INTENDED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE PRE FILTER FERRULE WAS ON TOO TIGHT. TOSOH BIOSCIENCE, INC. IS SUBMITTNG ON BEHALF OF THE FOREIGN MANUFACTURER TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT ISBEING 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.

    Description of Event or Problem · 0

    ON (B)(6) 2015 A CUSTOMER REPORTED A PRE-FILTER ISSUE, AND CANNOT CHANGE THE FILTER IT IS COMPLETELY STUCK WITH THE G8 ANALYZER. THE TECHNICAL SUPPORT SPECIALISTS ATTEMPTED TO INSTRUCT THE CUSTOMER VIA PHONE, WITHOUT SUCCESS. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. 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
    226140 TOSOH HLC-723G8 ANALYZER G8 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1