BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7301985 · Received February 28, 2018

    Report

    Report Number
    8031673-2018-00125
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE CHROMATOGRAM PROVIDED BY THE CUSTOMER SHOWED THAT THE PATIENT RESULT HAD H-PV3 FLAG, WHICH CLEARLY SHOWED THE P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUDES. THE PATIENT IN QUESTION HAS HBE VARIANT THAT IS KNOWN TO INTERFERE WITH TOSOH'S HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHODOLOGY. THIS PARTICULAR PATIENT SHOULD NOT BE TESTED WITH THE G8 METHODOLOGY. ON (B)(6) 2018, THE CUSTOMER'S SAMPLES WAS RECEIVED AND TESTED IN QA LAB. QA LAB FOUND THE SAMPLE TO BE DEGRADED. ON (B)(6) 2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE CUSTOMER'S REPORTED EVENT. FSE REPLACED THE PURGE AND UPTAKE CHECK VALVES, RAN FSE RAN QUALITY CONTROLS (QC) AND PATIENT PRECISION ON BOTH G8 INSTRUMENTS. ALL RESULTS WERE WITHIN ACCEPTABLE RANGE. PER THE G6 OPS MANUAL FLAG CODE 43 CAN BE USED TO DETECT THE PRESENCE OF A P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUTES. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 3, ASSAY OPERATIONS, STATES THAT THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 VARIANT ANALYSIS MODE CAN SEPARATE THE MAJOR VARIANT HEMOGLOBINS (HBD, HBS AND HBC). BUT SOME HEMOGLOBIN VARIANTS SUCH AS HBE CANNOT BE SEPARATED AND IT MAY INTERFERE WITH THE ASSAY. THE CHROMATOGRAM PATTERN FOR HEMOGLOBIN VARIANTS DIFFERS FROM THAT OF A NORMAL SAMPLE. IN ADDITION, THE G8 HAS KNOWN HBE INTERFERENCE. WHEN A SAMPLE IS SUSPECTED TO CONTAIN HBE, A FLAG WILL BE DISPLAYED. THE %HBA1C WILL NOT BE REPORTED FROM THE ANALYZER. CHAPTER 6, TROUBLESHOOTING, SECTION 6.4-ABNORMAL CHROMATOGRAMS STATES THAT 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. IN MOST CASES, RESULTS FOR THE SA1C% ARE REPORTABLE. IN SOME CASES, THE SA1C% MAY BE INVALID DEPENDING ON THE HEMOGLOBINOPATHY PRESENT, THE FLOW RATE, AND THE CONDITION OF THE COLUMN AND REAGENT SYSTEM. IN CHAPTER 1: INTRODUCTION AND APPLICATIONS STATES: THE G8 HAS KNOWN HBE INTERFERENCE. WHEN A SAMPLE IS SUSPECTED TO CONTAIN HBE, A FLAG WILL BE DISPLAYED. THE %HBA1C WILL NOT BE REPORTED FROM THE ANALYZER. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 HAS KNOWN HEMOGLOBIN E (HBE) INTERFERENCE. WHEN A SAMPLE IS SUSPECTED TO CONTAIN HBE A FLAG WILL BE DISPLAYED. THE HBA1C RESULT WILL NOT BE REPORTED FROM THE ANALYZER. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO AN IDENTIFIED HGB VARIANT FOR THE PATIENT IN QUESTION THAT IS KNOWN TO INTERFERE WITH THE G8 HPLC METHODOLOGY.

    Description of Event or Problem · 0

    ON (B)(6) 2018, CUSTOMER OBTAINED A HEMOGLOBIN A1C (HBA1C) PATIENT RESULT OF 8.5% WITH NO FLAG. THE PATIENT SAMPLE IN QUESTION WAS REPEATED IN ANOTHER G8 INSTRUMENT WITH A RESULT OF 7.2% (ASSAY RANGE 3.0 - 14.0 %) WITH A P-HV3 FLAG ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THE PATIENT HAS HISTORY OF HBA1C RESULTS OF 8.3% AND 8.5%. THE CUSTOMER SENT THE SAMPLE IN QUESTION OUT FOR CONFIRMATION AND OBTAINED A RESULT OF 5.7% WITH SIEMEN'S DCA ANALYZER. THE CUSTOMER PROVIDED CHROMATOGRAMS TO TECHNICAL SUPPORT SPECIALIST (TSS) WHICH CLEARLY SHOWED THE P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUDES. TSS RECEIVED FURTHER INFORMATION FROM THE CUSTOMER WHICH CONFIRMED THAT THE PATIENT WAS TESTED ON (B)(6) 2017 WITH HBA1C RESULT OF 8.3% WITH NO FLAG. THE PATIENT WAS DIAGNOSED WITH TYPE II DIABETES AFTER THE (B)(6) 2017 HBA1C RESULT OF 8.3%, AND TREATED WITH MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE CUSTOMER FOR PATIENT INFORMATION REGARDING TYPE OF MEDICATION ADMINISTERED AND WHETHER THERE WERE ANY ADVERSE HEALTH CONSEQUENCES. REFER TO MDR 3005529799-2018-00045.

    Additional Manufacturer Narrative · 1

    (B)(4) PER EXEMPTION NUMBER E2017013. ADDITIONAL INFORMATION: TOSOH BIOSCIENCE, INC. HAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF A PREVIOUSLY REPORTED EVENT UNDER MDR # IMPORTER # 3005529799-2018-00045 / MFR #8031673-2018-00045.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145900 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention