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	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A tosoh field service engineer (fse) assisted the customer with the reported event.The fse was unable to confirm or reproduce the error.The fse observed a dull sample needle, and a slightly loose drain flush valve.The fse replaced the sample needle, and tightened the drain flush valve.The fse cleaned the wash block, needle pathway, then cleaned and flushed the waste and dilution ports to verify valve function.The fse validated the analyzer by running quality control (qc) and patient samples with results within specification and no errors recurring.The analyzer is functioning as expected.No further actions required.A 13-month complaint and service history review through the aware date of event for similar complaints was performed for serial number (b)(6).There were no similar cases identified.Review of related documentation the g8 variant analysis mode operator's manual v 3.2 under section 1.8 and 1.9: section 1.8: interpretation of results: the sa1c measuring range is 4.0 ¿ 16.9%.The ideal retention time for sa1c is 0.59 minutes.The ideal retention time for a0 is 0.90 minutes.Results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see ¿abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However, a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.The chromatogram must be examined for any unidentifiable peaks (i.E., p00, p01,) before the a0 peak.Do not report the result if these peaks exist.When there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator¿s manual.Section 1.9: expected reference values: reference ranges (non-diabetic): hba1c 4.0-6.0 % (mean 5.0 %, sd 0.5 %) the diagnosis of diabetes and identification of persons at increased risk of developing diabetes follows the ada guideline of 6.5% for the cut-off and values between 5.7% and 6.4% as being at increased risk.The most probable cause is traced component failure of the sample needle.
Event or Problem Description
A customer reported discrepant a1c results on the tosoh g8 analyzer.The results showed hbe flags and high values, however the customer reported out results to the physician who questioned the high values.The customer tried to self-troubleshoot after the results were reported out by replacing the filter buffers and column.The customer then re-ran 200 patient samples from the previous week on the same tosoh analyzer, and 10 of these samples still had higher results compared to historical patient information.As a result, the customer decided to re-run some samples on a siemens atellica analyzer and found that the sa1c results were lower when tested on the atellica analyzer.The tosoh g8 analyzer gave results of 5.8%, whereas when testing the same patient samples on the atellica, the results was 5.1 %, which was within the expected range and lower than tosoh's results.The a1c results for atellica ranged between 4-5.6% and tosoh's acceptable a1c range is 4-6.0%.A tosoh field service engineer (fse) was dispatched to further investigate the reported event.There is 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: 20511242
• Report Number: 3004529019-2024-00635
• Device Sequence Number: 6931136
• 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): 10/23/2024

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-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: 09/27/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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