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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 13 month complaint history review and service history review for similar complaints was performed for serial (b)(4) from 03-mar-2017 through aware date 03-apr-2018.There were three (3) 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.In chapter 2 - preinstallation, under column use caution, the following was stated: 6-9 mpa is the ideal pressure, however, every instrument is slightly different and the combination of different columns with different instruments may sometimes show a slightly higher or lower pressure than the ideal 6-9 mpa.Some judgment may be necessary.On the column inspection report is a pressure specification, i.E., 5.1 mpa.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.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.In chapter 5, section 5.6 and 5.7 - column replacement & filter replacement, provides detailed instruction on how to replace the column and the filter.In chapter 6 - troubleshooting, section 6.3 - error messages: 101 pressure low: the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve.If the elution buffer is empty, place a new elution buffer and execute reagent change.Next, execute drain flush.See "chapter 5 section 5.5: pump air removal".Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times.If the pressure rises when the drain valve is closed, the operation is complete.If the pressure still does not rise or stabilize, execute drain flush again.In addition, confirm that the drain valve is securely closed.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 causes of the reported event was due to a faulty column and air in line.

Event Description

On (b)(6) 2018, a customer reported getting 101 low pressure after replacing the column on the g8 instrument.The customer had checked instrument connections for leaks and none was found.Technical support specialist (tss) instructed customer to disconnect tubing from column and perform drain flush for 10 minutes, but pressure is still low.Tss instructed customer to change filter and perform drain flush.The customer changed filter and pressure is 7.5.Tss instructed customer to change column and the pressure was in range after the column change.Customer successfully completed calibration and control runs; all results were within acceptable range.On (b)(6) 2018, the customer called back, reported getting low pressure after replacing the column on the g8 instrument.Customer stated the pressure is lower than expected at 8.19 mpa, quality control (qc) sa1crt=.66, flow factor (ff) = 1.12.Customer states that the column inspection report for this column indicates a pressure => 8.50.Customer also stated the system was inspected for any leaks, none was found.Technical support specialist (tss) assisted customer over the phone with the flow factor adjustment to 1.21.The customer ran qc and patient samples and sa1crt now = 0.59 (acceptable range is 0.57 to 0.61 minutes; optimal is 0.59 minute).Tss informed the customer that they will now need to re-calibrate and run qc due to the ff adjustments that were made.Customer was able to successfully complete calibration run and controls.All results were within acceptable range.The g8 instrument is functioning as intended.No further action required.

• 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
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7482143
• MDR Text Key: 107716562
• Report Number: 8031673-2018-00373
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Distributor Facility Aware Date: 04/03/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/02/2018
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1