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

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineering (fse) was at customer's site to resolve reported issue.Fse only found 1 qc c-gram that had missing peaks and it was on a qc sample that had area of 76 and looked like a short sample.Pump pressure was steady at ~7.6.Fse successfully completed qc run.Fse monitored buffer 3 while run was in progress, no expansion or filling with air was noted on buffer 3.Fse performed drain flush and noted buffer 3 bag stopper was broken.Fse replaced stopper, which might have been the cause of the reported issue.Fse completed qc and patient runs successfully; also pump pressure was stable.Fse adjusted flow factor (ff) from 1.02 to1.04; retention time (rt) is 0.59 - 0.60 (acceptable range is 0.57 to 0.61 minutes).The g8 instrument is functioning as intended.No further action required.A 13 month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no other similar complaints identified 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 probable cause of the reported event is air in system due to broken stopper.

Event Description

The customer reported the chromatography has many missing peaks on the g8 instrument.Customer has tried doing a flush because they suspect air in the system.The buffer 3 bag seems to be filling with air.The customer states that they replaced the bag because it was half empty, when they put the new bag on and dispelled all of the air.Pump pressure is low at 5.4.Column count 1900, filter 176.Technical support specialist (tss) instructed the customer to replace the column; the pump pressure still does not rise after column change.Customer states that buffer 3 bag is so full of air at this point that it is hard to the touch.Field service engineering 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 CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7753479
• MDR Text Key: 116871674
• Report Number: 8031673-2018-00560
• 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: Other
• Type of Report: Initial
• Report Date: 08/06/2018

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2018
• Distributor Facility Aware Date: 03/19/2018
• Device Age: 11 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/06/2018
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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