MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.During servicing, the distributor engineer replaced the column tubing and tightened the column fitting.The instrument was operating as expected.There was no further action required by the distributor engineer.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 17-nov-2017 through aware date (b)(4) 2018.There were two similar complaints, including this event, found during the searched period.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.Chapter 2 preinstallation states the following: 2.6 column connection.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.Column use cautions states the following: care must be taken to ensure that the solutions are delivered only in the direction indicated by the arrow on the name plate on the column being used.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.Safety precautions states the following: take great care of infections we strongly recommend that the operation be executed by the persons with full knowledge about clinical tests and how to handle potentially infectious materials.Blood to be tested might have been infected by pathogen.Misconduct on operation may bring infection to the operator or others working together.During operation take great care in handling test samples and use protectors such as glasses, gloves, mask to prevent infection when checking the system unit.Used column, filter, sampling needle and vial may have been contaminated.To dispose of these units and samples, follow the instructed procedure in compliance with regulations on medical waste.The most probable cause of the reported issue was due loose column connection.

Event Description

A customer reported that the retention times need constant adjustment on the g8 instrument.The instrument was down.A distributor engineer was dispatched to address the reported, which resulted in delay of reporting troponin (ctnl2) and creatine kinase-mb (ck-mb) patient results.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

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.Corrected data: see sections: b3; b5.

Event Description

A distributor engineer was dispatched to address the reported, which resulted in delay of reporting patient results.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 BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• MDR Report Key: 8255537
• MDR Text Key: 134976241
• Report Number: 3005529799-2019-00006
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/04/2019
• Distributor Facility Aware Date: 07/01/2019
• Date Report to Manufacturer: 07/04/2019
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1