BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7491676 · Received May 7, 2018

    Report

    Report Number
    8031673-2018-00420
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. ON (B)(6) 2018, FSE FOLLOWED UP WITH THE CUSTOMER VIA PHONE TO ADDRESS THE REPORTED EVENT. FSE ORDERED A REPLACEMENT PART TO BE SHIPPED TO THE SITE. ON (B)(6) 2018, FSE FOLLOWED UP WITH THE CUSTOMER AGAIN TO GET AN UPDATE ON HOW THE DEVICE WAS OPERATING AFTER THE PART HAD BEEN REPLACED. THE REPLACED PART WAS DISPOSED OF BY THE SITE. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER: (B)(4) FROM (B)(6) 2017 THROUGH (B)(6) 2018. THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 SERVICE MANUAL CHAPTER 4 & 6 - ASSAY OPERATIONS & MACHINERY AND THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING WERE REVIEWED. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: (B)(4) 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. 710 Z1-AXIS ERROR AN ABNORMALITY OCCURRED IN THE UP AND DOWN MOVEMENT OF THE SAMPLING NEEDLE. IF THIS OCCURS DURING A STAT ASSAY, CHECK THAT THE CONTAINER SETTING (CUP OR TUBE) IS CORRECTLY SET. THE ERROR ALSO OCCURS WHEN THE SAMPLE VIAL WAS NOT RECOGNIZED AS A PRIMARY TUBE, DUE TO THE DISORIENTED SAMPLE SENSOR. BENT SAMPLE NEEDLE: THE G8 SERVICE MANUAL UNDER CHAPTER 6-ASSAY OPERATIONS & MACHINERY INDICATES THAT: IF THE NEEDLE IS BENT IMMEDIATELY AFTER REPLACEMENT, CHECK THAT THE PRIMARY TUBES MATCH THE SAMPLE RACK OR SAMPLE RACK ADAPTER. IF THE NEEDLE PLACEMENT IS CLEARLY OFF-CENTER OF THE PRIMARY TUBE, IT MUST BE ADJUSTED. CHANGE THE "Y-SMP" PARAMETER. REFER TO PAGE 4-16. IF THE PRIMARY TUBES ARE LOOSE ON THE TOSOH RACK, ADJUST THE RACK'S HOLDER TO TIGHTLY HOLD THE PRIMARY TUBES. THE SAMPLING NEEDLE COULD BE BENT IF THE TUBES ARE LOOSE. INSERT THE PRIMARY TUBES STRAIGHT INTO THE RACKS. IF THE PRIMARY TUBE IS NOT SET STRAIGHT OR ITS BOTTOM IS NOT FIT TO THE RACK, THE SAMPLING NEEDLE COULD BE BENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A BENT SAMPLE NEEDLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE CUSTOMER REPORTED RECEIVING INTERMITTENT Z1 AXIS ERRORS WITH THEIR G8 ANALYZER. THE CUSTOMER STATED THAT WHEN THE SAMPLING NEEDLE ASSEMBLY EXITED THE TUBE AFTER SAMPLING IT DID NOT PUSH THE TUBE BACK DOWN INTO THE RACK. INSPECTION OF THE DEVICE REVEALED THAT THE SAMPLING NEEDLE ASSEMBLY WAS BENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE WAS 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
    333979 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1