BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLC-723 G8

    MDR report key: 19105106 · Received April 15, 2024

    Report

    Report Number
    3004529019-2024-00538
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 20, 2024
    Report Date
    April 15, 2024
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    PDJ
    UDI-DI
    04560189282919
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATIONS 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 HEMOGLOBIN VARIANT PEAKS WHEN CALCULATING THE TOTAL AREA. THE SA1C% IS USUALLY NOT AFFECTED IN SUCH SITUATIONS, ALTHOUGH CHROMATOGRAMS SHOULD BE CAREFULLY REVIEWED. VARIANT HEMOGLOBINS HBS (HV-1 PEAK), HBD (HV-0 PEAK) AND HBC (HV-2) ELUTE AFTER THE A0 PEAK. THE HBE (PHV3 PEAK) APPEARS BETWEEN SA1C AND HBA0. THE SA1C% IS REPORTABLE ON THE G8 WHEN THESE HEMOGLOBINS ARE PRESENT IN THE HETEROZYGOUS STATE WITH HBA. 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. REMEMBER THAT ALL ABNORMAL CHROMATOGRAMS ARE NOT NECESSARILY THE RESULT OF ABNORMALITIES IN THE PATIENT SAMPLE. ANALYZER PROBLEMS SUCH AS A MALFUNCTIONING PUMP OR SAMPLING UNIT, A COLUMN THAT SHOULD BE REPLACED OR REAGENTS THAT ARE INCORRECTLY PLACED OR HAVE BEEN DEPLETED CAN ALSO CAUSE ABNORMAL CHROMATOGRAMS. IN THESE CASES, SEQUENTIAL CHROMATOGRAMS ARE USUALLY ALL AFFECTED FROM THE POINT THAT THE PROBLEM BEGAN. THE INSTRUCTIONS FOR USE TSKGEL G8 VARIANT HSI SECTION 14. EVALUATION OF RESULTS STATES THE FOLLOWING: QUALITY CONTROL: IN ORDER TO MONITOR AND EVALUATE THE ACCURACY AND PRECISION OF THE ANALYTICAL PERFORMANCE, TOSOH CONTROLS SHOULD BE ASSAYED DAILY AND AFTER COLUMN REPLACEMENT. TOSOH SUGGESTS RUNNING AT LEAST TWO LEVELS OF QUALITY CONTROL MATERIAL. THE MEAN OF ONE SHOULD BE IN THE NON-DIABETIC RANGE (4-7 % HBA1C) WITH THE SECOND IN THE RANGE OF 9-12 % HBA1C. IF THE VALUE OF ONE OR MORE CONTROL SPECIMENS IS OUT OF THE ACCEPTABLE RANGE, RECALIBRATE THE SYSTEM AND RERUN THE CONTROLS BEFORE TESTING PATIENT SAMPLES. QC MATERIALS SHOULD BE USED IN ACCORDANCE WITH LOCAL, STATE, FEDERAL AND ACCREDITED ORGANIZATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED HBE FLAGS ON SEVERAL SAMPLES ON THE HLC-723 G8 ANALYZER. THE HBE FLAGS OCCURRED ON SEVERAL SAMPLES THAT HAD HIGHER THAN EXPECTED SA1C RESULTS. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLES WERE RERUN ON A POINT OF CARE DIFFERENT METHODOLOGY SYSTEM AND RESULTS WERE AS EXPECTED. THE TECHNICAL SUPPORT SPECIALIST (TSS) NOTED IT APPEARED THE HBE VARIANT VALUE WAS BEING ADDED TO THE SA1C RESULT. THE CUSTOMER NOTED THE RETENTION TIME (RT) WAS 0.57. THE TSS INSTRUCTED THE CUSTOMER TO LOWER THE FLOW FACTOR (FF) FROM 1.10 TO 1.07 AND RUN SEVERAL SAMPLES. THE RT IS NOW AT 0.59/0.58 WITH NO FLAGS OCCURRING. THE CUSTOMER WILL CALIBRATE. NO FURTHER FOLLOW UP OR ACTIONS REQUIRED FROM TSS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469829 HLC-723 G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723 G8 N/A 04560189282919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown