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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

On 19-mar-2018, a field service engineer followed-up with the customer over-the-phone and confirmed that the issue had been resolved after replacing the filter outlet flow line with the new one sent by tosoh technical support.The g8 instrument was working within specifications; no further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 16-feb-2017 through aware date 16-mar-2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 5, maintenance procedures, states the following: the 5.7 filter replacement: 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.The most probable cause of the reported event was due to salts or precipitate build up around the filter housing.(b)(4).

Event Description

On (b)(6) 2018, a customer reported not being able to reconnect the filter outlet flow line after the filter was replaced with a new one.The customer reported seeing white precipitation below the filter housing.The black screw was not moving and could not be screw back into the filter housing.The technical support specialist (tss) instructed the customer to remove the filter outlet flow line from the opposite end, but the customer was not able to do so.The tss suggested using warm water to dissolve any salt deposits; however, the customer was not able to do so as well.A new filter outlet flow line was sent to the customer for replacement and 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.

• 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 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); 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: 7431906
• MDR Text Key: 105880536
• Report Number: 8031673-2018-00307
• 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: 04/15/2018

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: 04/15/2018
• Distributor Facility Aware Date: 03/16/2018
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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