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

Model Number	HLC-723G8 ANALYZER
Medical Device Problem Codes	Device Emits Odor (1425); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the issue by attempting to turn the instrument on without success.The fse found a defective power supply and had trouble loading the software.The fse replaced the main board, but the issue persisted.The fse got a new copy of the software because the existing software card was bad.The fse did not find any burnt components on the analyzer; however, found a swollen and ruptured capacitor on the power supply that could emit a mild burning odor and likely does not produce any smoke.The fse replaced the switching power supply, which resolved the issue.The resolution was verified by running a patient sample and quality control run without error and within acceptable range.No further action required by field service.The g8 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed on the g8 analyzer for "burning smell from analyzer" issue from november 17, 2024 through aware date december 17, 2025.There were no similar complaints identified during the search period.A 13-month complaint history review and service history review for similar complaints was performed on the g8 analyzer for the "analyzer not powering on" issue from november 17, 2024 through aware date december 17, 2025.There were five similar complaints identified during the search period, including this case.The most probable cause of the reported event was due to a failed switching power supply, cause traced to component failure.
Event or Problem Description
A customer reported the g8 analyzer was not powering on: the power switch is not staying in the on position; it keeps going to the off position.The customer also reported a burning smell coming from the instrument, but no smoke was noted.A technical support specialist (tss) instructed the customer to plug the instrument into the main outlet, but the issue persists.The instrument and ups were left unplugged.The analyzer is down.A field service engineer (fse) was dispatched for further investigation.There is no indication of any patient intervention or adverse health consequences due to the reported event.

• 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: 24048936
• Report Number: 3004529019-2026-00002
• Device Sequence Number: 15789894
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 01/12/2026

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
• Device Lot Number: N/A
• 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: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2010
• 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