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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: this g8 instrument was installed at customer facility on 28-mar-2017.A (b)(6) complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.There was one (1x) similar complaint 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.In chapter 5- maintenance procedures, under daily checklist states: be sure to check the following items before starting analysis: (1) column, the maintenance schedule is 2500 tests; (2) filter, maintenance schedule if 400 tests.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 event was due to the flow factor adjustment and operator error.

Event Description

On (b)(6) 2018, a customer reported getting dashes and no results in place of the sa1c rt (retention time) value while running patient samples on the g8 instrument.Technical support specialist (tss) performed troubleshooting with the customer and identified the issue to be from a slow retention time (rt) of 0.56 minute (the acceptable range is 0.57 to 0.61 minutes; optimal is 0.59 minute).Tss assisted the customer with adjusting the flow factor which resulted in the retention time at 0.59 minute.The customer stated they do not have quality controls (qc) to run at the time, and ran patient samples instead.The customer verified the rt is still at 0.59 minute, the optimal value.Tss advised the customer to make qc material and verify that all qc is in range before reporting any patient results.Customer noted that the patient results were not reported out of the laboratory due to the retention time issue.It is not known whether hemoglobin a1c results were different before and after the retention time adjustment.There is no indication of any patient intervention or adverse health consequences due to this event.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• 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 (MANUFACTURER); 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: 7465373
• MDR Text Key: 107123463
• Report Number: 8031673-2018-00345
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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: 04/26/2018
• Distributor Facility Aware Date: 03/28/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/26/2018
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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