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

Model Number G8

Device Problem Leak/Splash (1354)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.When fse ran quality control (qc) chromatograms results good; however, when running patient samples there were no numbers/results and peaks were not detected.The customer informed fse that the device had recently been moved, and the new location had a drain setup where the drain line went down the hole in back of cabinet isle, ran along the back of backside, inside of a cabinet isle; them traveled and uphill for approximately 10 feet to a trap under a sink.This created an air pocket.The customer was unaware that the drain line was gravity fed and not drained via the pump.The waste line set up caused the waste to back up inside of the device because of the air pocket in the drain line.Fse disconnected the waste drain line from the instrument and ran a new waste line from the instrument down the same hole in the back of the cabinet to enter the waste container.He subsequently ran a few patient samples to test chromatograms and results were good.Fse, then recalibrated, ran qc, and a 10-point precision test to verify that the device was operating as expected.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial (b)(4) from 08apr2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 2- preinstallation, states the following: waste tube insert the waste tube firmly into the waste port located on the bottom of the main unit.(refer to fig.2-9).Securely tighten the waste tube with the tie wrap provided in the accessory box.Insert the other end of the tube into the waste bottle.(refer to fig.2-10) note: if the waste tube is bent, the waste liquid may not drain out smoothly.Adjust (cut) the tube length to keep the tube end above the waste liquid level.When changing the analyzer location, make sure that the tube is not loose, broken or bent and that the waste liquid drains unobstructed.The sample loader must also be temporarily disconnected when changing the analyzer location.Please contact the authorized representatives.1.If the waste tube is bent and waste liquid cannot drain, the sample dilution may not be accurately performed during the assay.2.Keep the waste tube end above the top of the waste liquid.The most probable cause of the reported event was due to an air pocket that was not draining from the waste drain line due to its placement.

Event Description

It was reported that the customer experienced a leak at the drain valve with their g8 analyzer.The customer stated that she changed the column yesterday and that is when she noticed the leak.Additionally, the customer stated they are getting no results on samples.The customer stated that the waste was empty.Inspection of the waste tubing did not reveal any kinks.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 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 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
• 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: 7545215
• MDR Text Key: 109751848
• Report Number: 8031673-2018-00479
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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: 05/25/2018
• Distributor Facility Aware Date: 05/08/2018
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/25/2018
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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