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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative/data (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse replaced the purge and uptake valves on the analyzer and ran precision, quality controls (qc), and patient samples.All results and the retention times were within acceptable range.The g8 instrument is functioning as intended, the flag 35 cleared.No further action required from field service.A 13 month complaint history review and service history review for similar complaints was performed for (b)(4) from (b)(6) 2017 through aware date (b)(6) 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.The most probable cause of the reported event was due to defective check valves.

Event Description

On (b)(6) 2018, a customer reported getting flag 35 retention time of sa1c peak with retention time of 0.56 min (the acceptable range is 0.57 to 0.61 minutes; optimal is 0.59 minute) on the g8 instrument.Customer stated can adjust the flow rate, but requested service to see if the check valves need to be replaced.On (b)(6) 2018, field service engineer (fse) was dispatched to address the reported issue.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

The pump check valves were received for in-house investigation.The parts were found to have no visible damage or any other observable issues.Chemistry linearity test was performed with the valves to obtain chromatograph measurements using in-house test instrument.The retention time was found to result within acceptable range of 0.59 to 0.61 minutes.Investigation could not confirm the reported issue.The pump valves passed functional tests.The most probable cause of the reported event could not be determined.

• 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: 7398437
• MDR Text Key: 104539732
• Report Number: 8031673-2018-00290
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/08/2018
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1