BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8003972 · Received October 25, 2018

    Report

    Report Number
    8031673-2018-00696
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    August 5, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THIS RECORD IS BEING SUBMITTED LATE AS PART OF A RETROSPECTIVE REVIEW PER (B)(4), COMPLAINT RETROSPECTIVE REVIEW AND REMEDIATION PROTOCOL. THE PROBABLE CAUSE OF THIS EVENT WAS A DEFECTIVE FILTER. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FROM THE AWARE DATE OF THE EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR HLC-723G8 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4) AND THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: ABNORMAL CHROMATOGRAMS. ALTHOUGH THE PERCENTAGE OF EACH HEMOGLOBIN COMPONENT MAY VARY SLIGHTLY FROM PATIENT TO PATIENT, MOST WHOLE BLOOD SAMPLES WILL CONTAIN SIX FRACTIONS: A1A, A1B, F, LA1C+, SA1C, AND A0. A NORMAL CHROMATOGRAM IS SHOWN BELOW IN FIGURE 6-2. 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. MATHEMATICAL ALGORITHMS USED IN THE SOFTWARE EXCLUDE VARIANT PEAKS ELUTING AFTER THE A0 PEAK WHEN CALCULATING THE TOTAL AREA. THE SA1C% IS USUALLY NOT AFFECTED IN SUCH SITUATIONS, ALTHOUGH CHROMATOGRAMS SHOULD BE CAREFULLY REVIEWED. HBS, HBD AND HBC ELUTE AFTER THE A0 PEAK. THE SA1C% IS GENERALLY REPORTABLE ON THE G8 WHEN THESE HEMOGLOBINS ARE PRESENT IN THE HETEROZYGOUS STATE WITH HBA. 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. FLAG CODE 43 CAN BE USED TO DETECT THE PRESENCE OF A P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUTES. (SEE CHAPTER 4, SECTION 4.18 "FLAG PARAMETER SETTING" FOR A DESCRIPTION OF FLAG SETTINGS). GLYCEMIC MONITORING FOR PATIENTS DISPLAYING ANY HOMOZYGOUS HEMOGLOBIN OTHER THAN HBAA SUCH AS HBSS, HBCC OR THE DOUBLE HETEROZYGOUS HBSC, CANNOT BE PERFORMED USING SA1C BECAUSE THERE IS NO HBA PRESENT. ALTERNATIVE TESTING IS MANDATORY FOR THESE TYPES OF PATIENTS. THE HEMOGLOBIN A1C ST AIA-PACK HBA1C ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). USING ST AIA-PACK HBA1C, THE HIGHEST CONCENTRATION OF HBA1C MEASURABLE IS 14.0%, AND THE LOWEST MEASURABLE CONCENTRATION IS 3.0%. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 3 ASSAY OPERATIONS, STATES THE FOLLOWING: 3.6 CALIBRATION. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 HAS A TWO-POINT AUTOMATIC CALIBRATION FUNCTION FOR STABLE HBA1C (SA1C). WHEN THE ANALYZER PROCESSES CALIBRATORS, IT CALCULATES THE SLOPE AND INTERCEPT FROM A LINEAR REGRESSION EQUATION TO DETERMINE QUANTITATIVE RESULTS FOR PATIENT SAMPLES AND CONTROLS. USE ONLY THE TOSOH HEMOGLOBIN A1C CALIBRATOR SET (P/N: 018767) FOR CALIBRATION OF THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8. OTHER CALIBRATORS CANNOT BE USED AND MAY GIVE ERRONEOUS RESULTS. EACH LABORATORY MUST MONITOR QC RESULTS ACCORDING TO GOOD LABORATORY PRACTICES TO DETERMINE WHEN TO RECALIBRATE. CALIBRATION FREQUENCY SHOULD BE BASED UPON QC RESULTS AND CHROMATOGRAM QUALITY. WE RECOMMEND CALIBRATING THE ANALYZER ONCE A WEEK. THE LABORATORY MAY ESTABLISH A LONGER CALIBRATION INTERVAL BASED ON DAILY QC RESULTS. BE SURE TO CALIBRATE IN THE FOLLOWING SITUATIONS: IF DRIFT IN QC IS NOTED. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 IS A VERY PRECISE INSTRUMENT AND YOU WILL NOTE THAT THE QC REMAINS THE SAME DAY AFTER DAY. IF THERE IS A DRIFT IN QC VALUES, IT IS NECESSARY TO RECALIBRATE. WHEN CONTROL VALUES ASSAYED ARE OUT OF RANGE CALIBRATE WHEN THE CONTROL ASSAY VALUE FALLS OUTSIDE THE QC RANGE. MEASURE THE CONTROL SAMPLE AGAIN TO CONFIRM THAT IT FALLS WITHIN THE QC RANGE BEFORE ASSAYING A PATIENT SAMPLE. AFTER COLUMN REPLACEMENT CALIBRATE AFTER A NEW COLUMN HAS BEEN INSTALLED. AFTER ANALYZER MAINTENANCE CALIBRATE AFTER PERIODIC MAINTENANCE OR REPAIR. WHEN AN ASSAY CONDITION IS BEING MODIFIED CALIBRATE WHEN A PARAMETER VALUE (SUCH AS THE FLOW FACTOR) IS BEING CHANGED ON THE ANALYZER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A CALIBRATION ERROR, WITH MISSING PEAKS AND P00 AND H-VAR PEAKS ON THE HLC-723G8 ANALYZER. THE CUSTOMER REPORTED THAT THE COLUMN WAS NEW. THE CUSTOMER PROCEEDED TO RUN WHOLE BLOOD SAMPLES WITH NO P00 AND H-VAR PEAKS, A1C RETENTION TIME OF 0.61 MINUTES AND NO ERRORS. THE CUSTOMER WAS INSTRUCTED TO RUN CALIBRATORS AS QUALITY CONTROLS AND OBTAINED OUT OF RANGE LOW RESULTS WITH P00 PEAKS. THE TECHNICAL SUPPORT SPECIALIST A NEW COLUMN TO THE CUSTOMER FOR REPLACEMENT. TWO DAYS LATER THE CUSTOMER REPORTED THAT AFTER REPLACING THE FILTER CALIBRATION PASSED WITHOUT ANY ERRORS. QUALITY CONTROLS RECOVERED WITHIN ACCEPTABLE RANGE AS WELL. THE DELAY IN ADDRESSING THE PROBLEM RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845104 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1