BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLC-723 G8

    MDR report key: 19844902 · Received July 26, 2024

    Report

    Report Number
    3004529019-2024-00590
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 1, 2024
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    PDJ
    PMA / PMN Number
    K200904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME - HLC-723 G8. SECTION D4: UNDER UDI NUMBER- (B)(4). SECTION G3/G4 PMA/510(K)NUMBER - K200904.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER OVER THE PHONE AND WAS ABLE TO CONFIRMED THE REPORTED ISSUE BY REVIEWING THE RESULTS. THE FSE COULD HEAR THE GRINDING NOISE WHILE THE CUSTOMER WAS OPERATING ON THE ANALYZER. THE FSE SUSPECTED THE SMALL SYRINGE WAS THE ROOT CAUSE OF THE REPORTED ISSUES. THE SMALL SYRINGE NOT BEING PROPERLY LUBRICATED RESULTED IN THE AUDIBLE NOISE OF RESISTANCE FROM FRICTION IN THE RANGE OF MOTION OF THE SYRINGE. THIS WAS ALSO CAUSING IMPROPER DILUTION OF THE PATIENT SAMPLES WHICH COULD AFFECT THE SAMPLE RESULTS. THE FSE INSTRUCTED THE CUSTOMER TO LUBRICATE THE SMALL SYRINGE, RUN CALIBRATION AND CONTROLS WITH RESULTS WITHIN ACCEPTABLE RANGE. THE CUSTOMER ALSO RAN 10 PATIENT SAMPLES TO COMPARE WITH A SEPARATE ANALYZER AND THE RESULTS CORRELATED WITHIN 0.2% OF EACH OTHER. THE HLC-723 G8 ANALYZER IS OPERATING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM INSTALL DATE THROUGH AWARE DATE. 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 WAS TRACED TO MAINTENANCE; THE SAMPLE SYRINGE NEEDED PROPER LUBRICATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED POTENTIAL DISCREPANT RESULTS ON MULTIPLE PATIENT SAMPLES AND A GRINDING NOISE ON THE HLC-723 G8 ANALYZER. THE CUSTOMER PROVIDED THE RESULTS FOR ONE PATIENT SAMPLE; THE INITIAL SAMPLE RESULT WAS 6.2%. THE PHYSICIAN QUESTIONED THE RESULTS AND THE CUSTOMER RERAN THE SAMPLE ON TWO OTHER G8 ANALYZER WITH RESULTS OF 5.8% FROM BOTH ANALYZERS. THE CUSTOMER STATED THEY REPLACED THE SAMPLE NEEDLE, LUBRICATED GUIDE RODS, RESEATED THE COLUMN AND RECALIBRATED WITH RESULTS WITHIN ACCEPTABLE RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE. 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
    459909 HLC-723 G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723G8LA ANALYZER REFURBISHED N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown