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

Model Number G8

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse found that adjusting the flow factor did not correct the reported issue.The fse verified the reported issue on site per the patient results.The pump pressure was unstable.The fse replaced the faulty pump assembly, set the flow factor (ff) to 1.08 ml/min and the retention time was 0.59 minutes.The fse verified precision, calibration, and quality control (qc).All results were within acceptable range.All errors cleared and the g8 instrument was operational.No further actions were required by field service.A (b)(6)-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from (b)(6) 2017 through (b)(6) 2018.There were no similar complaints identified during the searched period, which includes this event.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 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 for the reported event was the pump failure.

Event Description

A customer reported p00 peaks on samples and quality controls (qc) on the g8 instrument.The customer stated that the retention times were running long, 0.63-0.65 minutes.The column count was 1500 injections, the filter was new, and the pump pressure was 8.2 mpa.Technical support (ts) advised the customer to adjust the flow rate from 1.24 ml/min to 1.28 ml/min.The customer wanted to continue to run so the flow rate was adjusted.The customer ran whole blood samples to check retention times, 0.58, 0.60, 0.62, 0.62, and 0.61 minutes.Ts advised the customer to recalibrate and to run qc.The customer is aware of the retention time range of 0.57-0.61 minutes.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4), 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.The pump assembly was returned for investigation to the instrument service center (isc).Functional testing of the returned part was conducted and found that the part failed.The error was duplicated.The most probable cause for the reported event was the pump failure.Additional device information: the udi was updated to the correct number.

• Brand Name: TOSOH HLC-723GA ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 7717115
• MDR Text Key: 114945348
• Report Number: 8031673-2018-00656
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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: 07/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2018
• Distributor Facility Aware Date: 07/06/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/17/2018
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1