BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7197753 · Received January 16, 2018

    Report

    Report Number
    8031673-2017-00298
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 19, 2017
    Report Date
    August 23, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. H.3. DEVICE EVALUATION BY MANUFACTURER: NO CONCLUSION IS YET AVAILABLE; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER: (B)(4) FROM 19-JAN-2016 THROUGH AWARE DATE 19-FEB-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. 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. CHAPTER 4, SCREEN OPERATIONS, UNDER FLAG CONDITIONS STATES THAT A FLAG INDICATES THAT THE RESULT IS GREATER THAN THE ASSIGNED CUT-OFF VALUE. 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. 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. CORRECTED DATA: FOR CORRECTED DATA REFER TO: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVALUATION. PMA/510(K). DEVICE MANUFACTURE DATE. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED A POTENTIAL ERRONEOUS RESULT FOR HEMOGLOBIN A1C (HBA1C) ON A PATIENT SAMPLE WITH THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE PATIENT CONSISTENTLY TESTED AROUND 7.0% ON HEMOGLOBIN A1C (HBA1C); HOWEVER, THE PATIENT COMPLAINED TO THE PHYSICIAN BECAUSE OF AN HBA1C RESULT OF A 5.6% AT ANOTHER LAB. THE CHROMATOGRAMS FROM THE G8 INSTRUMENT SHOWED THAT THE PATIENT HAD BEEN TESTED ON THREE (3) OCCASIONS; (B)(6) 2017 WITH AN HBA1C RESULT OF 7.2%, (B)(6) 2017 WITH AN HBA1C RESULT OF 7.1%, AND (B)(6) 2017 WITH AN HBA1C RESULT OF 7.2%. THERE WERE NO FLAGS GENERATED AND RETENTION TIMES WERE WITHIN ACCEPTABLE RANGES OF 0.59 TO 0.60 MINUTES (ACCEPTABLE RANGE 0.57 TO 0.60 MINUTES). THE TOSOH TECHNICAL SUPPORT SPECIALIST NOTED THAT THE A0 PEAK HAD A SMALLER PEAK COMING OFF RIGHT AFTER THE SA1C, WHICH INDICATES A POSSIBLE HEMOGLOBIN E (HBE) INTERFERENCE. THE TSS ADVISED THE CUSTOMER THAT THIS PARTICULAR PATIENT SHOULD NOT BE TESTED BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC). THE CUSTOMER WAS TO SEND THE SUBJECT PATIENT SAMPLE TO BE TESTED ON A DIFFERENT METHOD. NO ADVERSE EFFECT TO PATIENT MANAGEMENT WAS REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38262 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1