BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7885381 · Received September 18, 2018

    Report

    Report Number
    8031673-2018-00864
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 31, 2018
    Report Date
    October 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THE DEVICE WAS INSTALLED AT THE SITE ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 4 SCREEN OPERATIONS & CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 4.18 FLAG PARAMETERS: FLAG 24- REPORT IF ONLY ONE UNKNOWN PEAK WAS DETECTED; FLAG 43- REPORT IF P-HV3 PEAK WAS DETECTED. TO ENABLE, SET AS "43 > 9999.99". 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. 211 PEAK PATTERN ERROR: EXPLANATION: PEAKS WERE NOT SEPARATED WELL. COUNTERMEASURE: CHECK THE SAMPLES, BUFFERS, AND HEMOLYSIS & WASH SOLUTION. 6.4 ABNORMAL CHROMATOGRAMS: CHROMATOGRAMS FROM PATIENTS WITH HEMOGLOBIN VARIANTS OR UNKNOWN PEAKS NOT RECOGNIZED BY THE ANALYZER ARE OCCASIONALLY SEEN DURING ROUTINE TESTING. THESE PATTERNS MAY INDICATE INTERFERENCES OR PROBLEMS WITH THE ASSAY. THEREFORE, IT IS IMPORTANT TO USE CAUTION WHEN TROUBLESHOOTING. REVIEW ALL CHROMATOGRAMS TO DETERMINE WHETHER THE RESULTS ARE VALID. FLAG CODE 43 CAN BE USED TO DETECT THE PRESENCE OF A P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUTES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE PUMP ASSEMBLY.

    Additional Manufacturer Narrative · 0

    TOSOH HAS CONFIRMED THAT THIS REPORT IS DUPLICATE OF THE EVENT REPORTED UNDER MFR REPORT #: 8031673-2018-00864 AND UF/IMPORTER REPORT #: (B)(4). TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBERE2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVING FLAG 43 AND "211 PEAK PATTERN" ERRORS ON THEIR G8 ANALYZER. THE COLUMN COUNT WAS REPORTED TO BE 1787 INJECTIONS AND SA1C RETENTION TIME (RT) WAS 0.53 MINUTES. THE CUSTOMER IS REQUESTING SERVICE. THE CUSTOMER CALLED BACK TO STATE THAT THEY HAD ALSO RECEIVED FLAG 24, ONE UNKNOWN PEAK DETECTED. 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
    724907 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1