BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 20002118 · Received August 20, 2024

    Report

    Report Number
    3004529019-2024-00600
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 17, 2024
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    PDJ
    UDI-DI
    04560189282919
    PMA / PMN Number
    K200904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TSS INSTRUCTED THE CUSTOMER TO ADJUST THE FLOW FACTOR (FF) FROM 1.04 TO 0.98, AND TO RECALIBRATE THE G8 ANALYZER, WHICH RESOLVED THE OUT OF RANGE HIGH ISSUE. THE CUSTOMER VALIDATED THE ANALYZER BY SUCCESSFULLY PERFORMING QUALITY CONTROL AND RETEST OF THE INITIAL PATIENT SAMPLE WITHOUT ANY HBE FLAG OR ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION IS REQUIRED. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW THROUGH THE AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. REVIEW OF RELATED DOCUMENTATION. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL V 3.3 UNDER SECTIONS 1.9 AND CHAPTER 6 STATES THE FOLLOWING: SECTION 1.9: EXPECTED REFERENCE VALUES: REFERENCE RANGES (NON-DIABETIC): HBA1C 4.0-6.0 % (MEAN 5.0 %, SD 0.5 %) THE DIAGNOSIS OF DIABETES AND IDENTIFICATION OF PERSONS AT INCREASED RISK OF DEVELOPING DIABETES FOLLOWS THE ADA GUIDELINE OF 6.5% FOR THE CUT-OFF AND VALUES BETWEEN 5.7% AND 6.4% AS BEING AT INCREASED RISK. CHAPTER 6 TROUBLESHOOTING. 6.4 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 MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED HEMOGLOBIN E (HBE) FLAG FOR AN ISOLATED PATIENT SA1C SAMPLE ON A G8 ANALYZER. THE CUSTOMER STATED THAT THEY REPORTED THE INITIAL SA1C TEST RESULT OF 6.7% WITH A RETENTION TIME (RT) OF 5.7 AND AN HBE FLAG DETECTED. IN ADDITION TO THE HBE FLAG DETECTED, THE TEST RESULT OF 6.7% WAS OUT OF RANGE HIGH. THE CUSTOMER REPEATED THE TEST WITH THE SAME RT OF 5.7, RESULTING IN AN SA1C OF 5.4% BUT WITH NO HBE FLAG. THE CUSTOMER THEN REPEATED THE TEST FOR A THIRD TIME AND REPORTED OUT THE RESULT, WHICH WAS AN SA1C OF 5.4%. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT. A TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) ASSISTED THE CUSTOMER WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396738 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