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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the (b)(6) of 2017 through awareness date on the (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 5- daily check, states the following: a 5.7 filter replacement.Replace the filter in the following cases.When the filter counter reaches 400 injections.When the pressure is more than what is indicated on the column inspection report + 4 mpa.The filter has been in contact with blood samples.Wear protective clothing such as glasses, gloves, mask, etc., and take sufficient care to prevent infection during replacement and handling.If the analyzer is not in stand-by state, wait for the assay to end and stand-by to be displayed.You can also change the state to stand-by state by pressing the stop key.Open the door below the display.Confirm on the main screen (the second screen) that the sv1 key is open (o).Remove the filter outlet (top) flow line.Turn the top of the filter holder assembly by turning it counterclockwise and remove the filter holder by pulling it straight out.Lightly press the top of the holder to take out the old filter element.Place the new element with great care of surface of filter.The gray colored surface is the outlet (up) side.Firmly tighten the top of the filter holder assembly by hand until no further tightening is possible.Place a lab wipe at the filter holder outlet and run the pump by pressing the key to remove the air inside the element.Check that no more bubbles come from the outlet side, and then press the key to stop the pump.Connect the outlet side flow tube.Press the key again to start the elution buffer delivery.Make sure that the pressure falls within a range less than the original pressure (which is indicated on the column inspection report) + 4 mpa and that there are no leaks from the filter housing components and tube connections.If a leak is found, tighten the assembly further.After installing a new filter, reset (zero) the filter counter on the reagent change screen.Once the filter is tightened it will become deformed and cannot be used again.The most probable cause of the reported issue was due to the filter.(b)(4).

Event Description

The customer reported that mid run after quality control and 30 samples the g8 analyzer stopped giving results or total areas.The customer changed the filter and elution buffer #1 in response to the reported error, which did not resolve the issue.The technical support specialist (tss) had the customer perform drain flush procedure to rule out air in the lines.Customer reported that the drain flush procedure did not resolve the problem and the pressure is 9.4 mpa which is within range of 7-11 mpa.Then the tss had the customer check the waste tube to ensure that it was immersed properly into the waste buffer bottle and that there was no backup in the waste tubing.The customer reported back that there was no waste backup and the waste tube was immersed in the liquid.Customer reported to the tss that the column count (cc) was at 5800 injection counts.The tss requested the customer to replace the column since the operator's manual recommends the column to be replaced at 2500 injections.The customer informed the tss they don't have a new column or a new sample needle.Tss advised the customer to order the column and the new sample needle.On a follow up call with the customer the tss was informed that the customer replaced the filter, which resolved the reported issue.The customer did not provide any further details or explanations.The reported event resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7564064
• MDR Text Key: 110345075
• Report Number: 8031673-2018-00491
• 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: 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/02/2018
• Distributor Facility Aware Date: 05/10/2018
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2018
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2008
• 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