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

Model Number G8

Device Problem Obstruction of Flow (2423)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) was at customer's site to address the reported event.Fse inspected the instrument and noticed the flow rate was at 1.19 with low pressure of 7.23 mpa and sa1c rt was at 0.65.Fse determined the check valve was clogged, and was able to replace the valve.Fse also adjusted the flow rate to 1.08 and the pressure was now at 8.45mpa and sa1c rt now at 0.60.The customer successfully completed quality control without any errors.No further action required by fse.The g8 instrument is functioning as expected.A 13 month complaint history review and service history review for similar complaints was performed for serial number (b)(4).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.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 g8 operator's manual under chapter 6, troubleshooting, states the following: 211 peak pattern error is generated when peaks were not separated well.The operator is instructed to check the samples, buffers, and hemolysis & wash solution.The most probable cause of the reported event is due to clogged check valves.

Event Description

The customer reported getting 211 peak pattern error and p00 peaks while running quality controls (qc) on the g8 instrument.The customer stated that both qc levels had sa1c retention (rt) of 0.63 (acceptable range is 0.57 to 0.61 minutes).Customer calibrated and adjusted flow factor (ff) but sa1c rt stayed fast.Field service engineering was dispatched to address the reported event, which resulted in delay of reporting hba1c patient results.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

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.Device evaluation by manufacturer: the purge and uptake check valves were returned to tosoh instrument service center (isc) for investigation.Functional testing confirmed defective valves.Parts will be discarded.The most probable cause of the reported event is due to faulty uptake and purge valves.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 7920858
• MDR Text Key: 124969259
• Report Number: 8031673-2018-00872
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• 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: 09/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Distributor Facility Aware Date: 09/29/2018
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/18/2018
• Date Manufacturer Received: 09/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1