MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER

Model Number G8

Device Problems High Readings (2459); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 16-jan-2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse confirmed the la1b was not detected and the poo peaks for sa1c was low in the chromatogram.Fse identified the source to be frozen elution buffer #2 the customer was using.Fse replaced the column and used an unfrozen buffer that was at the facility to run the analyzer.Fse then performed calibration and ran quality controls (qc).All results were within acceptable range.The g8 instrument functions as intended.Fse ordered new elution buffer that was scheduled to be delivered to the facility by 23-jan-2018.No further action required from field service.A 13 month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 16-dec-2016 through 16-jan-2018.There were no other similar complaints identified during the searched period.The g8 operator's manual under chapter 1 - introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.In chapter 5- maintenance procedures, under daily checklist states: be sure to check the following items before starting analysis: (1) column, the maintenance schedule is 2500 tests; (2) filter, maintenance schedule if 400 tests.The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.Chapter 1 - introduction and applications under 1.4 storage and stability indicates that unopened g8 variant elution buffers hsi (s) 1, 2, and 3 are stable until the expiration date printed on the label.After opening, elution buffers are stable for three months.Store at 4-30°c.The most probable cause of the reported event was due to the use of frozen eluent buffer.

Event Description

On (b)(6) 2018, a customer reported getting fast retention time (rt) of 0.64 minute (the acceptable range is 0.57 to 0.61 minutes) on the g8 instrument.Per customer, the column was recently changed and the column count was 400 (maximum recommended change is at 2500 injections).Technical support specialist (tss) had the customer adjust the flow factor from 1.11 to 1.14; the retention time was higher to 0.65 minutes.Field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.On (b)(6) 2018, customer also reported not getting results on quality controls (qc) or patient samples and could not identify the buffer reagents.Tss suspected customer was using frozen reagents and ordered new buffer reagents for the customer.On (b)(6) 2018, customer emailed tss that they used unfrozen buffers and was able to run qc and patient samples successfully.The chromatograms showed normal peaks and the retention time was within acceptable range.It is not known whether hemoglobin a1c results were different before and after the retention time adjustment.There is no indication of any patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Follow up type.Corrected data.Age of device : 6 years.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 7275838
• MDR Text Key: 100471718
• Report Number: 8031673-2018-00060
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Distributor Facility Aware Date: 03/23/2019
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/03/2019
• Date Manufacturer Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1