BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7043775 · Received November 17, 2017

    Report

    Report Number
    8031673-2017-00112
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 29, 2017
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. CORRECTED DATA: 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 20-OCT-2017 A FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BARCODE READER WAS DAMAGED. THE FSE ORDERED A NEW BARCODE SCANNER AND INSTRUCTED THE CUSTOMER TO REPLACE IT UPON ARRIVAL AT THE SITE. ON 24-OCT-2017 ON A FOLLOW-UP CALL THE CUSTOMER CONFIRMED THAT THE NEW BARCODE SCANNER WAS INSTALLED SUCCESSFULLY. THE CUSTOMER REPORTED THAT THE BARCODE READER ISSUE HAD BEEN RESOLVED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 19-SEP-2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DAMAGED BAR CODE READER.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED THAT THE G8 INSTRUMENT READ THE FIRST TWO BARCODE LABELS, BUT SKIPPED THE REST OF THE RACK OR READ ONLY THE LAST ONE WHILE RUNNING PATIENT SAMPLES. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON HEMOGLOBIN A1C (HBA1C) AS THE ERROR PERSISTED. 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
    822112 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1