BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7181432 · Received January 10, 2018

    Report

    Report Number
    8031673-2017-00269
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 12, 2017
    Report Date
    May 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. DEVICE EVALUATION BY MANUFACTURER: NO CONCLUSION IS YET AVAILABLE; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Additional Manufacturer Narrative · 0

    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: THE CUSTOMER DID NOT SEND THE SAMPLE IN QUESTION TO BE FURTHER TESTED BY ANOTHER METHOD. THE CUSTOMER HAS BEEN ADVISED THAT THIS PARTICULAR PATIENT SHOULD NOT BE TESTED BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC). A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 13663609 FROM 12-NOV-2016 THROUGH AWARE DATE (B)(6)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 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.

    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 RESULT PRESENTED WITH A HEMOGLOBIN E (HBE) INTERFERENCE FLAG. THE PATIENT HAS BEEN PREVIOUSLY TESTED AT THE LAB AND HAS NOT BEEN FLAGGED FOR HBE INTERFERENCE. THE CUSTOMER REPORTED THAT THE PATIENT DID PRESENT WITH HBE INTERFERENCE IN 2015 AND HAS BEEN TESTED FIVE (5) OTHER TIMES WITHOUT ANY FLAG. THE CUSTOMER REPORTED REPEATING THE SUBJECT PATIENT SAMPLE A FEW TIMES BUT THE FLAG DID NOT CLEAR. THE TOSOH TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO SEND THE SUBJECT PATIENT SAMPLE OUT TO BE TESTED ON ANOTHER METHOD. THE TSS ADVISED THE CUSTOMER THAT THIS PARTICULAR PATIENT SHOULD NOT BE TESTED BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC). THE TSS REQUESTED THE PATIENT CHROMATOGRAM FOR FURTHER REVIEW. NO ADVERSE EFFECT TO PATIENT MANAGEMENT WAS REPORTED AND NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24498 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1