BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLC-723 G8

    MDR report key: 19644652 · Received July 1, 2024

    Report

    Report Number
    3004529019-2024-00575
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 1, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED TECHNICAL SUPPORT SPECIALIST (TSS) STATING THAT THEY HAD CALIBRATED THE INSTRUMENT THEN RERAN QUALITY CONTROL (QC), CALIBRATORS AS PATIENT SAMPLES, AND THE SURVEY SAMPLE. THE CUSTOMER WAS STILL NOT SATISFIED AFTER RUNNING CALIBRATOR LEVEL 1 AND LEVEL 2. THE CUSTOMER RAN LINEARITY TO ENSURE THE INSTRUMENT WAS PERFORMING AS EXPECTED. THE SAMPLES WERE ALL WITHIN THE ACCEPTABLE HEMOGLOBIN A1C RANGE. 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 SEARCH 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED FAILURE OF COLLEGE OF AMERICAN PATHOLOGISTS (CAP) GH5 2024 PROFICIENCY TESTING FOR HEMOGLOBIN A1C (HBA1C) SURVEY SAMPLE GH-02 ON THE G8 ANALYZER. THE CUSTOMER NOTED THAT ALL OTHER SAMPLE RESULTS WERE ACCEPTABLE, BUT ABOVE THE MEAN AND CLOSE TO HIGH RANGE. THE CUSTOMER CONFIRMED QUALITY CONTROL (QC) RESULTS WERE IN RANGE AND THE CURRENT COLUMN COUNT (CC) FOR COLUMN LOT S WAS AT 1800. THE CUSTOMER ONLY CALIBRATES MONTHLY, AND THE TECHNICAL SUPPORT SPECIALIST (TSS) SUGGESTED THE CUSTOMER INCREASE CALIBRATION FREQUENCY. THE CUSTOMER CHANGED TO COLUMN LOT T AND REPEATED GH-02 SURVEY SAMPLE WITH RESULT WITHIN ACCEPTABLE RANGE. 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
    566181 HLC-723 G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723 G8 04560189282919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown