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	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported ¿discrepant hbe suspected¿ flag for multiple samples on the g8 analyzer.The issue occurred about a week ago, and the patient¿s sample results were reported out to the physician, who questioned the reported findings and requested a rerun.The customer stated the issues were resolved by replacing the column and buffers.Tosoh was not informed of complaint at occurrence, and resolved issue prior to reporting to tosoh.No other information was provided by the customer.The customer reported the complaint for documentation purposes, no troubleshooting required at this time.No further follow up or actions required from tosoh.There was no indication of any patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number 15440001.There were two other similar complaints found during the searched period including this case.The g8 variant analysis mode operator¿s manual v 3.4 under chapter 6: 6.4 abnormal chromatograms.Chromatograms from patients with hemoglobin variants or unknown peaks not recognized by the analyzer are occasionally seen during routine testing.These patterns may indicate interferences or problems with the assay.Therefore, it is important to use caution when troubleshooting.Review all chromatograms to determine whether the results are valid.In most cases, results for the s-a1c% are reportable.In some cases, the s-a1c% may be invalid depending on the hemoglobinopathy present, the flow rate, and the condition of the column and reagent system.The g8 variant analysis mode operator¿s manual v 3.4 under chapter 1: introduction and applications: 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 event could not be established.

• 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: 21446862
• Report Number: 3004529019-2025-00694
• Device Sequence Number: 15253114
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/24/2025

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
• 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: 01/31/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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