MAUDE Adverse Event Report: TOSOH HI-TEC, INC. HLC-723; 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	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most probable cause is not yet determined, investigation pending.
Event or Problem Description
A customer reported potential discrepant patient results for hba1c on the hlc-723 g8 analyzer.The patient result was 8.7% (non-diabetic range 4.0-6.0%), which was consistent with the past few results.Due to expecting a lower result, the physician questioned the patient result.The patient sample was retested at a different lab using trinity premier affinity and received a result of 6.0%, reference range is unknown.The customer stated they reviewed all of the patient sample results from the past year and found no other results that were questionable.The customer also confirmed there were no issues with quality control (qc).The customer stated they will redraw the patient sample and send out for hemoglobin electrophoresis testing.There is no indication of any patient intervention or adverse health consequences due to the potential discrepant patient results.

• Brand Name: HLC-723
• 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 ; 2-2-1 yaesu; chuo-ku, toyoko 14002-8 ; JA 140028 ; 6506368314
• MDR Report Key: 25107365
• Report Number: 3004529019-2026-00060
• Device Sequence Number: 21400636
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• 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): 05/06/2026

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: 0021560
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown