BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8144829 · Received December 8, 2018

    Report

    Report Number
    8031673-2018-05316
    Event Type
    Malfunction
    Date Received
    December 8, 2018
    Date of Event
    November 19, 2018
    Report Date
    February 1, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLING NEEDLE ASSEMBLY AND ONE ROTOR AND STATOR FOR REODYNE VALVE WERE RETURNED FOR EVALUATION TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) WITH NO SHIPPING DAMAGE. VISUAL INSPECTION OF THE SAMPLING NEEDLE ASSEMBLY REVEALED A BENT/ DEFORMED TIP. FUNCTIONAL TESTING OF THE ROTOR AND STATOR FOR REODYNE VALVES PASSED. THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL INSPECTION OF THE SAMPLING NEEDLE ASSEMBLY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE LARGE SYRINGE GEARS REQUIRING LUBRICATION AND MECHANICAL DAMAGE OF THE SAMPLING NEEDLE TIP. 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

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE REPORTED EVENT VIA THE ERROR LOG AND BY VISUALIZING AND HEARING THE LARGE SYRINGE BIND. FSE RESOLVED THE COMPLAINT BY LUBRICATING THE LARGE SYRINGE, AND BY REPLACING THE ROTOR SEAL AND STATOR FACE DUE TO WEAR, AND SAMPLING NEEDLE ASSEMBLY DUE TO A POSSIBLE CLOG. FSE WAS SUBSEQUENTLY ABLE TO RUN QUALITY CONTROL (QC) WITHOUT ISSUE. 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)(6) FROM 19OCT2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE "706 SYRINGE-L" ERROR WITH THEIR G8 ANALYZER. TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO CLEAN THE LEAD SCREWS ON THE LARGE SYRINGE, FLUSH OUT THE STRAIGHT SAMPLE PROBE, PRIME AND RE-RUN; HOWEVER, THE ERROR PERSISTED. 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 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
    984569 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1