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

Model Number G8

Device Problems Mechanical Problem (1384); Pressure Problem (3012)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.Fse verified the issues with printouts and lack of pressure through all pumps.Fse replaced the uptake and purge valves and verified the pressure was good through all pumps.Fse then lubricated the guide rails for the sample unit and needle.The wash well and bottom of needle were cleaned of debris.Fse then performed quality controls (qc) with acceptable results.The instrument was verified as operational.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 07-aug-2017 through aware date (b)(4) 2018.There was one similar complaint found during the search 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 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 worn uptake and purge check valves.

Event Description

A customer reported they were getting fluctuating sa1c retention times (rt) and pressures while running the g8 instrument.The customer stated that the rts were between 0.50-0.60 minutes and pressure was running between 5.0 and then 8-9 mpa.The column count and the total areas were normal and within specifications and the analyzer was running with the same lot number.There were no drainage issues or leaking noted.The customer reported that they were using tosoh quality control (qc) lot 7081.The customer stated that the first few chromatograms had expanded peaks which improved after a few runs, but the sa1crt and the pressure was still fluctuating.The customer ran a whole blood sample with acceptable results.Technical support (ts) advised the customer to restart the instrument and run primes.A 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 is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, (b)(4), per exemption number e2017013.The uptake and purge check valves were returned for evaluation.Functional testing was performed and the parts failed testing.The instrument experienced low pressure and an incorrect chromatography.The error was reproduced.The issue was confirmed.

• 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 10586 23; JA 1058623
• MDR Report Key: 7922854
• MDR Text Key: 125120274
• Report Number: 8031673-2018-00880
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• 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: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2018
• Distributor Facility Aware Date: 11/29/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/06/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1