MAUDE Adverse Event Report: TOSOH HI-TEC, INC. G8; HEMOGLOBIN A1C TEST SYSTEM

Model Number	HLC-723G8 ANALYZER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(6) from the 21oct2024 through aware date of 21nov2025.There were two similar complaints identified during the searched period, including this case.A 13-month complaint history review and service history review for similar complaints was performed for hba1c with check peaks flag from 21oct2024 through aware date of 21nov2025.There were three similar complaints identified during the searched period, including this case.The g8 variant analysis mode operator¿s manual v 3.3 under chapter 1, section: 1.8: 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.Chapter 1, 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 g8 variant analysis mode operator's training manual under chapter 4: flag codes code 24 (flag 24): check peaks description: unknown peak(s) found in the chromatogram.The most probable cause of the reported discrepant result was not established.
Event or Problem Description
A customer reported ¿discrepant patient results for hba1c with check peak (flag 24)¿ during patient run on the g8 analyzer.The customer stated the results were reported to the physician and no patient treatment was affected.The initial patient result was 7.6% with flag 24 (check peaks).The customer replaced the column prior to the run and did not prime.The technical support specialist (tss) instructed the customer to replace the filter and prime with samples.After priming, the samples flagged on the low end retention time (rt) 0.57 minutes (rt range 0.57-0.61 minutes, however the ideal rt is.59 minutes).The tss also instructed the customer to lower the flow factor from 1.04 to 1.01, which raised the rt to 0.59 minutes.The customer reran the sample and result was 6.0%, which was within the physician¿s expected range (non-diabetic range 4.0-6.0%).The column count is 152 (max recommended injection is 2500) and filter count is 394 (max recommended value is 400).No further action required by technical support.The g8 analyzer is functioning as expected.There is no indication of any patient intervention or adverse health consequences due to the reported discrepant patient result.

• Brand Name: G8
• Common Device Name: HEMOGLOBIN A1C TEST SYSTEM
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 23864191
• Report Number: 3004529019-2025-00076
• Device Sequence Number: 18666566
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K200904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HLC-723G8 ANALYZER
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown