BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6907534 · Received October 2, 2017

    Report

    Report Number
    8031673-2017-00042
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    August 31, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH HI-TEC
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLING NEEDLE ASSEMBLY WAS DEFECTIVE. THE FSE REPLACED THE SAMPLING NEEDLE ASSEMBLY IN ORDER TO RESOLVE THE REPORTED ISSUE. THE INSTRUMENT WAS FUNCTIONING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW WAS PERFORMED FROM 31-JUL-2017 THROUGH 31-AUG-2017 FOR (B)(4) FOR SIMILAR COMPLAINTS. NO SIMILAR COMPLAINTS WERE FOUND DURING THIS SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL STATES UNDER CHAPTER 6, TROUBLESHOOTING, INDICATES THAT 706 SYRINGE-L ERROR MESSAGE OCCURS WHEN AN OPERATION ERROR IN THE SYRINGE-L IS ENCOUNTERED. THE OPERATOR IS INSTRUCTED TO INSPECT THE SYRINGE-L. CHAPTER 5, MAINTENANCE PROCEDURES, SECTION 5.10 PROVIDES STEP-BY-STEP INSTRUCTIONS ON REPLACING A DEFECTIVE SAMPLING NEEDLE ASSEMBLY. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS RELATED TO A DEFECTIVE SAMPLING NEEDLE ASSEMBLY.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 706 SYRINGE-L ERROR MESSAGE ON THE G8 SYSTEM WHILE RUNNING PATIENT SAMPLES. THE CUSTOMER PERFORMED SEVERAL TROUBLESHOOTING STEPS WITHOUT RESOLUTION. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON HBA1C. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE 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
    686357 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH HI-TEC G8

    Patients

    Seq Age Sex Outcome Treatment
    1