BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 19823613 · Received July 24, 2024

    Report

    Report Number
    3004529019-2024-00589
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 25, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT SPECIALIST (TSS) FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER DID NOT SEND OUT SAMPLES FOR REPEAT PATIENT TESTING. THE CUSTOMER OPTED TO USE THE RESULT FROM THE ALTERNATE METHOD. TSS COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. TSS CONFIRMED THE ANALYZER IS FUNCTIONING AS EXPECTED. THE DISCREPANT RESULT FOR SA1C PATIENT SAMPLE WAS AN ISOLATED EVENT DUE TO POSSIBLE TREATMENT FOR A SINGLE SAMPLE. NO FURTHER ACTION REQUIRED BY TOSOH. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 03JUN2023 THROUGH AWARE DATE 03JUL2024. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR¿S MANUAL V 3.3 UNDER CHAPTER 1: INTRODUCTION AND APPLICATIONS: 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 DISCREPANT RESULT FOR SA1C COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ¿ONE (1) DISCREPANT PATIENT SAMPLE RESULT FOR SA1C¿ ON THE G8 ANALYZER. THE CUSTOMER RAN THE PATIENT SAMPLE AND RESULT WAS 7.9% AND REPORTED OUT THE RESULT TO THE PHYSICIAN WHO QUESTIONED THE REPORTED RESULT AND REQUESTED A RETEST USING CAPILLARY BLOOD GLUCOSE TEST (FINGER PRICK BLOOD TEST) FOR COMPARISON. THE RETEST RESULT WAS 6.9%, WHICH WAS A MORE EXPECTED VALUE BASED ON PATIENT¿S HISTORY RESULTS. THE RETENTION TIME (RT) WAS WITHIN SPECIFICATIONS AND NO FLAGS ON CHROMATOGRAMS NOTED. THE CUSTOMER PERFORMED CALIBRATIONS AND QUALITY CONTROL (QC) WHICH WAS WITHIN EXPECTED RANGES. THE TECHNICAL SUPPORT SPECIALIST (TSS) REQUESTED THE CUSTOMER TO SEND OUT ANOTHER SAMPLE FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANT PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343680 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