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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a (b)(6) complaint history review and service history review for similar complaints was performed for the g8, 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 1.4 storage and stability: the unopened tskgel g8 variant hsi column should be stored at 4-15°c in a cool location away from direct sunlight.The column is stable until the expiration date printed on the label.Columns are warranted for 2500 injections.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 g8 variant analysis mode operator's manual under chapter 1, introduction and applications, section 1.6 - procedures provides detailed information on column preparation and installation.In chapter 5: maintenance procedures, section 5.6 - column replacement provides detailed information on how to replace the column.The most probable cause of the event is due to column injection count beyond warranty.

Event Description

On (b)(6) 2018 a customer reported getting many samples with p00 peaks and missing peaks on the g8 instrument.Customer stated retention time is too fast at 0.65 (acceptable range is 0.57 to 0.61 minutes), column count: 3000 (maximum recommended 2500 injections), filter count 210.The technical support specialist (tss) instructed the customer to adjust flow rate from 1.09 to 1.14.Customer ran samples to check retention times; it was still high at 0.64.Tss instructed customer to adjust the retention time to 1.18, and retention time was adjusted but remained high at 0.64.Tss informed the customer the column needs to be changed before running any samples.Tss sent a new column to customer and will follow up with customer when column is received.This resulted in delay in reporting of hba1c patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.On (b)(6) 2018, the customer followed up with tss, stating receipt of the new column.Tss walked customer through over the phone on how to replace the column and check for leaks.Replacement was completed, pump pressure is 9.36.Customer then ran 5 samples for priming and retention time is 0.56.Tss had the customer adjust the flow rate to 1.10.Customer then ran the 5 samples again with retention times of 0.60.Customer then calibrated and ran controls, controls are within range and retention times 0.61.Customer confirmed no forward problems experienced.G8 instrument is functioning as expected.

• 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: 7478486
• MDR Text Key: 107462672
• Report Number: 8031673-2018-00370
• 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: 05/01/2018

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: 05/01/2018
• Distributor Facility Aware Date: 04/03/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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