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

Model Number G8

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Device Operational Issue (2914)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on (b)(6) 2017 a field service engineer (fse) found that the i-3 tubing had popped out of the nut and the ferrule from the injection valve port.The fse removed the nut and ferrule from the valve and the nut seemed loose.The fse reseated the i-3 tubing with the nut and ferrule properly.The fse also checked and secured all other nut fittings.The fse found that the column was not properly installed, causing a leak.The fse installed the column properly, performed system flush, and restarted the instrument with no issues.The fse ran quality controls and noticed that the flow factor needed adjustment.The fse adjusted the flow factor for proper retention time.The fse ran quality controls and precision, which passed.The instrument was performing within specifications after completing the repair.A 13-month complaint history review and service history review for similar complaints was performed for serial number 12130403 from 13-sep-2016 through (b)(6) 2017.There were two (2) similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 1 - introduction and applications, states that dilution studies demonstrate that the assay is linear from a total area of 500 to 4000.However, the optimum total area is 700 to 3000.Results will not be reported if the total area (ta) is <500 and if the ta is >4000.Section 1.6, procedures, provide step-by step instructions on proper column installation.Section 2.6, column connection instructs the following: take the column out of the box and remove the protective plugs on both ends.Do not throw away these plugs as they are needed for storage.2) be sure that buffer delivery has been completely stopped (the status "stand-by" is displayed on the main screen).Open the column oven and disconnect the flow line, and remove the used column.3) press the arrow key located on the lower right side of the screen.The key for manual buffer delivery is displayed.Use the key to run the pump and confirm that buffer is being delivered from the column flow line end.Use the key to stop the pump.Be careful not to spill the buffer draining from the flow line onto the unit.Wipe with paper if necessary.4) verify the proper column flow direction, which is drawn on the label, by an arrow and connect the flow line to the inlet side of the column.Use the screen key to run the pump and verify that buffer is draining from the outlet side of the column.Stop the pump and connect the outlet side of the column to the flow line.5) use the screen key to start the pump again, verify that the pressure is rising quickly and that there is no leakage at the flow line connection.After that, stop the pump and close the column oven.6) select the reagent key from the mainte screen, press the col.Reset key, and reset the column counter to zero.The most likely cause of the reported event was due to the i-3 tubing being disconnected from the injection valve port.

Event Description

On (b)(6) 2017 a customer reported getting low total areas while running hemoglobin a1c (hba1c) on patient samples with the g8 instrument.The customer replaced the column, which was at 8100 injections (2500 maximum recommended), but issue was not resolved.The customer is unable to run patient samples on hba1c.On (b)(6) 2017 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

Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

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.

• 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, 105-8 623; JA 105-8623
• MDR Report Key: 7023182
• MDR Text Key: 92805162
• Report Number: 8031673-2017-00101
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2019
• Distributor Facility Aware Date: 10/13/2017
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1