BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8

    MDR report key: 19473814 · Received June 5, 2024

    Report

    Report Number
    3004529019-2024-00567
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 6, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) ASSISTED THE CUSTOMER WITH THE REPORTED EVENT. THE CUSTOMER INFORMED THE TSS THAT THEY REPEATED THE PROFICIENCY SAMPLE AND RECEIVED ACCEPTABLE RESULT AFTER PERFORMING A PERIODIC MAINTENANCE (PM) AND RECALIBRATING THE G8 ANALYZER. THE CUSTOMER VALIDATED THE ANALYZER BY SUCCESSFULLY RUNNING QUALITY CONTROL WITHOUT ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH THE AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WAS A TOTAL OF 2 SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD, INCLUDING THIS ONE. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL V 3.2 UNDER SECTION 1.8 AND 1.9: SECTION 1.8: INTERPRETATION OF RESULTS: THE SA1C MEASURING RANGE IS 4.0 ¿ 16.9%. THE IDEAL RETENTION TIME FOR SA1C IS 0.59 MINUTES. THE IDEAL RETENTION TIME FOR A0 IS 0.90 MINUTES. 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. 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A FAILED COLLEGE OF AMERICAN PATHOLOGIST (CAP) SURVEY GH5 A 2024 CAP NUMBER 1664901 01 FOR THE G8 ANALYZER. THE CUSTOMER STATED THAT A NEW COLUMN WAS INSTALLED, AND CONFIRMED THE COLUMN, BUFFERS AND HEMOLYSIS WASH WERE PROPERLY STORED AND HANDLED BEFORE TESTING. NO CALIBRATION ISSUES REPORTED, QUALITY CONTROL (QC) WAS WITHIN ACCEPTABLE RANGE. TOSOH CAP SURVEY RESULTS WERE ALL IN 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
    2054359 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