BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 22903516 · Received August 27, 2025

    Report

    Report Number
    3004529019-2025-00018
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    PDJ
    UDI-DI
    04560189282926
    PMA / PMN Number
    K200904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION G3/G4: PMA/510(K)NUMBER: PREVIOUSLY REPORTED: K131580. CORRECTED NUMBER: K200904.

    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 FOUND DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS OPERATOR'S MANUAL UNDER CHAPTER 1 STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE: TOTAL AREA: DILUTION STUDIES DEMONSTRATE THAT THE ASSAY IS LINEAR FROM A TOTAL AREA OF 500 TO 4000. HOWEVER, THE OPTIMUM TOTAL AREA IS 700 TO 3000. ABNORMAL RED CELL SURVIVAL THE LIFE SPAN OF RED BLOOD CELLS IS SHORTENED IN PATIENTS WITH HEMOLYTIC ANEMIAS, AND THE ACTUAL LIFE SPAN DEPENDS UPON THE SEVERITY OF THE ANEMIA. AS A CONSEQUENCE, SPECIMENS FROM SUCH PATIENTS MAY EXHIBIT DECREASED GLYCOHEMOGLOBIN LEVELS COMPARED TO PATIENTS WITH NORMAL RED CELL LIFE SPAN. THE LIFE SPAN OF RED BLOOD CELLS IS LENGTHENED IN POLYCYTHEMIA OR POST-SPLENECTOMY PATIENTS. SPECIMENS FROM SUCH PATIENTS MAY EXHIBIT INCREASED GLYCOHEMOGLOBIN LEVELS. HEMOGLOBINOPATHIES: THE MOST COMMONLY OBSERVED HEMOGLOBIN VARIANTS ARE HBS, HBC, HBD AND HBE. THESE VARIANTS IN THEIR HETEROZYGOUS STATE ELUTE AFTER THE HBA0 PEAK IN THEIR DESIGNATED WINDOWS: HBS (H-V1 PEAK), HBD (H-V0 PEAK) AND HBC (H-V2 PEAK). THE HBE (P-HV3 PEAK) APPEARS BETWEEN SA1C AND HBA0 PEAKS. IN ALL THESE CASES, THE SA1C% IS REPORTABLE WHEN THESE HEMOGLOBIN VARIANTS ARE PRESENT IN THE HETEROZYGOUS STATE. WHEN EITHER OF THESE HEMOGLOBIN VARIANTS IS IDENTIFIED, THE SA1C% IS CALCULATED IN A PROPRIETARY WAY, DEPENDING ON THE TYPE OF HEMOGLOBIN VARIANT, BASED ON THE AREA OF SA1C, THE AREA OF IDENTIFIED HEMOGLOBIN VARIANT AND OTHER PEAKS. WHEN A P-HV3 PEAK IS DETECTED, A FLAG 43 IS ALSO REPORTED. GLYCEMIC MONITORING FOR ANY PATIENTS DISPLAYING ANY HOMOZYGOUS HEMOGLOBIN (OTHER THAN HBAA) SUCH AS HBSS, HBCC OR THE DOUBLE HETEROZYGOUS SC, CANNOT BE PERFORMED USING SA1C BECAUSE THERE IS NO HEMOGLOBIN A PRESENT. ALTERNATIVE TESTING IS MANDATORY FOR THESE TYPES OF PATIENTS. INTERPRETATION OF RESULTS: THE SA1C MEASURING RANGE IS (B)(4). THE IDEAL RETENTION TIME FOR SA1C IS (B)(4). THE IDEAL RETENTION TIME FOR A0 IS (B)(4). RESULTS WILL NOT BE REPORTED IF THE TOTAL AREA (TA) IS <500 WHICH CAN BE SEEN IN SEVERE ANEMIA. RESULTS WILL NOT BE REPORTED IF THE TA IS >4000 WHICH CAN BE SEEN IN POLYCYTHEMIA. (SEE ¿ABNORMAL RED CELL SURVIVAL IN PREVIOUS SECTION). THE OPTIMAL GOAL FOR TOTAL AREA IS BETWEEN 700-3000. HOWEVER, A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. THE CHROMATOGRAM MUST BE EXAMINED FOR ANY UNIDENTIFIABLE PEAKS (I.E., P00, P01,) BEFORE THE A0 PEAK. DO NOT REPORT THE RESULT IF THESE PEAKS EXIST. WHEN THERE IS A QUESTION CONCERNING THE CHROMATOGRAPHY, REPEAT THE SAMPLE. IF THE REPEATED SAMPLE ALSO DISPLAYS UNUSUAL CHARACTERISTICS, IT IS APPROPRIATE TO EVALUATE WHETHER THE UNUSUAL RESULT IS DUE TO AN ABNORMAL SAMPLE, A PROCEDURAL ERROR, AN INSTRUMENT MALFUNCTION OR A SAMPLE-HANDLING PROBLEM. FOR FURTHER INFORMATION, SEE THE TROUBLESHOOTING SECTION IN THIS OPERATOR¿S MANUAL. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS TRACED TO THE USER FAILING TO REVIEW CHROMATOGRAMS PRIOR TO RELEASING RESULTS TO PATIENT PHYSICIAN.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED INCORRECTLY REPORTED PATIENT RESULTS FOR HBA1C ON THE HLC-723 G8 ANALYZER. THE CUSTOMER STATED THE PATIENT'S PHYSICIAN QUESTIONED THE UNEXPECTED HIGH PATIENT RESULTS. THE CUSTOMER STATED THEY REVIEWED CHROMATOGRAMS AND FOUND SEVERAL SAMPLES WITH HBE FLAGS AS WELL AS LOW RETENTION TIME. THE CUSTOMER STATED THEY ADJUSTED THE FLOW FACTOR TO RAISE THE RETENTION TIME TO AN ACCEPTABLE NUMBER, THEN RERAN ALL SAMPLES THAT ORIGINALLY PRODUCED A RESULT WITH A HBE FLAG RESULT. THE CUSTOMER CLARIFIED THAT THE LAB TECHNICIAN RUNNING SAMPLES FOR THE DAY DID NOT REALIZE THAT THE AMOUNT OF HBE FLAGS RECEIVED WAS NOT NORMAL AND FAILED TO LOOK INTO THE REASON FOR THE NUMEROUS HBE FLAGS PRIOR TO REPORTING OUT THE RESULTS. THE CUSTOMER DID NOT PROVIDE TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) WITH ANY OF THE REPORTED PATIENT RESULTS, NOR WERE ANY PATIENT TREATMENT AFFECTED. THE CUSTOMER STATED THEY ONLY REPORTED THE ISSUE FOR DOCUMENTATION PURPOSES AND DID NOT REQUIRE ANY FURTHER ACTION FROM TSS. TECHNICAL SUPPORT SPECIALIST (TSS) DETERMINED THE CAUSE OF THE REPORTED EVENT WAS TRACED TO USER ERROR. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. 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
    1467794 G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723 G8 LA 04560189282926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown