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 11/05/2018

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 pump and check valves.The distributor engineer also adjusted the retention time.Quality controls were run with acceptable results.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 (b)(4) 2017 through aware date (b)(4) 2018.There were no similar complaints 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.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.The most probable cause of the reported issue was due to a bad pump unit.

Event Description

A customer reported that the retention times (rt) were running fast on the g8 instrument.The instrument was down.A distributor engineer was dispatched to address the reported, which resulted in delay of reporting hga1c 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
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8255534
• MDR Text Key: 134743044
• Report Number: 3005529799-2019-00016
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2019

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
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2012
• 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