BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7405578 · Received April 7, 2018

    Report

    Report Number
    8031673-2018-00273
    Event Type
    Malfunction
    Date Received
    April 7, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2018, A FIELD SERVICE ENGINEER (FSE) VERIFIED THE 706 SYRINGE-L ERROR MESSAGE, PLUS THE GRINDING NOISE AS THE SYRINGE MOVE UP AND DOWN ON THE G8 INSTRUMENT. THE FSE REPLACED THE LARGE SYRINGE ASSEMBLY TO ADDRESS THE ISSUE. THE FSE THEN PROCEEDED TO CALIBRATE AND RUN QUALITY CONTROLS WITHOUT ANY ISSUES. NO FURTHER ACTION WAS REQUIRED BY THE FSE. G8 INSTRUMENT WAS FUNCTIONING AS DESIGNED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 09-FEB-2017 THROUGH AWARE DATE 09-MAR-2018. THERE WERE THREE (3) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 6.3 ERROR MESSAGES WHEN CONSULTING WITH TECHNICAL SUPPORT ABOUT A PROBLEM, PLEASE NOTE THE ERROR MESSAGE AND ERROR NUMBER. IN ADDITION, IF YOU FOLLOW THE SUGGESTED SOLUTIONS IN THIS SECTION AND ARE STILL UNABLE TO RESOLVE THE ERROR, OR IF YOU ENCOUNTER AN ERROR MESSAGE THAT IS NOT NOTED, CONTACT TECHNICAL SUPPORT. GENERAL ERROR MESSAGES WITH THESE ERRORS, THE ASSAY STOPS AND THE ANALYZER IMMEDIATELY ENTERS STAND-BY STATE. 706 SYRINGE-L ERROR EXPLANATION: OPERATION ERROR IN SYRINGE-L. COUNTERMEASURE: INSPECT X1-AXIS. INSPECT SYRINGE-L. EXECUTE SMP.RESET. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY LARGE SYRINGE LEAD SCREW. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING 706 SYRINGE-L ERROR MESSAGES WITH THE G8 INSTRUMENT. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REPLACE THE COLUMN AND RUN FIVE (5) PRIME SAMPLES; THE ERROR PERSISTED WITH THE FIRST RUN. THE CUSTOMER REPORTED A LOUD SQUEAKING NOISE WAS COMING FROM THE INSTRUMENT AND COULD NOT RUN. THE CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (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
    248374 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1