MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) HLC-723G8; HEMOGLOBIN A1C TEST SYSTEM

Model Number	HLC-723G8 REFURBISHED
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	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported fluctuating sample results on the g8 analyzer.The results were reported out to the patient's doctor who questioned them because several of the sample results were higher than expected.No treatment was changed based on the fluctuating results.The retention time was at 0.57 minutes, acceptable range is 0.56-0.62 minutes.Since the retention time was on the lower end of the acceptable range, the customer changed the flow factor from 1.09 to 1.06.After the adjustment, the customer reran the samples and they matched the expected results.The customer calibrated and the g8 analyzer is functioning as expected.No further action is required.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 for similar complaints was performed for the serial number (b)(6) through aware date.There were no similar complaints identified during the search period.The g8 variant analysis operator's manual under chapter 1 states the following: 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 g8 variant analysis operator's manual under "chapter 4: screen operations" states the following: flow factor: pump flow factor: this factor is arranging the speed through the column and will influence the retention time.High flow rate is faster elution and vice versa.Never change this parameter without instruction from the service personnel.The most probable cause of the reported event was traced to maintenance; the retention time needed to be adjusted.

• Brand Name: HLC-723G8
• Common Device Name: HEMOGLOBIN A1C TEST SYSTEM
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 20641885
• Report Number: 3005529799-2024-00044
• Device Sequence Number: 20698987
• Product Code: PDJ
• UDI-Device Identifier: 00853931008009
• UDI-Public: 00853931008009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/08/2024

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 REFURBISHED
• Device Catalogue Number: 021560R
• 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: 10/11/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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