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	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was at the customer site to address the reported event.The fse confirmed the reported error by viewing the error logs and records documented by clinical support specialist (css) during installation of the analyzer.Upon review, the fse found that the calibrations performed by css were lower than expected, results for level 1 were 4.3% and level 2 was 8.2% (compared to the expected level 1, 4.7% and level 2, 9.3%), with no flags noted.The quality control (qc) performed by css was slightly below the mean, recorded at 5.3% and 11.3%.The following day, the qc values increased, shifting to 5.7% and 12.3%, as observed by the customer in correlation with patient history results.The fse advised the customer to contact tosoh support specialists (tss) for guidance if there are any concerns regarding calibrators, qc, or patient results.As the analyzer was already due for calibration, the customer performed recalibration and both qc and patient results returned to normal, the qc values were 5.3% and 11.2%.The fse also noticed the retention times (rt) were 0.57 minutes and 0.58 minutes and adjusted the flow factor and rt is within specifications.In addition, the fse ran controls and patient samples, and qc was close to the mean for level 1 and level 2.Fse could not determine the cause of the reported event.No further action is 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 for serial number (b)(6) from 11jan2024 through aware date 11feb2025.There were no similar complaints identified during the search period.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 result for hba1c could not be established.
Event or Problem Description
A customer reported ¿discrepant patient results for hba1c¿ on the g8 analyzer.The patient sample result of 7.4% was reported out to the physician who questioned the result and requested the sample to be reran.The sample was sent out to quest laboratory using enzymatic methodology and resulted with 6.2%, which is consistent with patient¿s history result of 6.2%.No patient treatment was affected.The customer stated the quality control (qc) was within ranges, but concerned sample is running higher than usual.A field service engineer (fse) was dispatched to further investigate the reported event.There was no indication of any patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
Correction for h10 section: incorrect statement: a 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from 11jan2024 through aware date 11feb2025.There were no similar complaints identified during the search period.Correct statement: the g8 analyzer, serial number (b)(6) was installed on 10jan2025.A complaint history review and service history review for similar complaints was performed from installation date 10jan2025 through aware date 11feb2025.There were no similar complaints identified during this searched period.

• 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: 21554863
• Report Number: 3004529019-2025-00701
• Device Sequence Number: 4450713
• Product Code: PDJ
• UDI-Device Identifier: 04560189282919
• UDI-Public: 04560189282919
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/17/2025

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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/08/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown