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

Model Number	HLC-723 G8
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	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from 21mar2024 through aware date 21apr2025.There were four similar complaints identified for check peak flags during the search period, including this case and no similar complaints identified for leak.The g8 variant analysis mode operator¿s manual v 3.4 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 results for hba1c was due to the leak due to loosen connection between the column heater and tubing.
Event or Problem Description
A customer reported ¿two (2) discrepant patient results for hba1c and a leak at the column heater¿ on the g8 analyzer.The customer stated the left side of the connection of the heater was leaking.The results were reported out and no values or patient information provided.The customer tightened the fitting at the column heater that connects to the tubing and resolved the leaking issue prior to calling technical support specialist (tss).Tss instructed the customer to check the pressure and were within specifications.The customer replaced the filter and noticed check peak flags.The retention time (rt) was 0.57 minutes.The customer mentioned they reran the two patient samples after the leak was fixed and were within acceptable ranges.Tss had the customer change the flow factor (ff) from 1.08 to 1.05 and rt is reading at 0.59 minutes with no flags recurring.The investigation determined that an increased pump speed corrected the rt and resolved the complaint.The customer successfully performed calibration with no reported issues.No further action required by tosoh.The g8 analyzer is functioning as expected.There was 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: 21998308
• Report Number: 3004529019-2025-00726
• Device Sequence Number: 12922048
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/09/2025

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-723 G8
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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