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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 09-mar-2018, fse was at customer's site to resolve reported event.Fse confirmed complaint by reviewing instrument chromatogram.Fse replaced pump valve and plunger.Fse checked and cleaned seals and rotor, and proactively changed the filters.Fse validated instrument by calibrating and running controls without any p00 peaks, controls were within acceptable range and retention time at 0.59.No further action required by field service.The g8 instrument is functioning as expected.A 13-month 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 two (2) similar complaints identified during the searched period, which includes this event.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.In chapter 4 - screen operations, section 4.6- parameter setting also states: flow factor: pump flow factor.Never change this parameter without instruction from technical support.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 most probable cause of the high retention time is due to worn plunger causing erratic retention times.

Event Description

On (b)(6) 2018, a customer reported p00 peaks while running controls on the g8 instrument.Customer stated column count is 566, retention time is 0.65 (rt acceptable range is 0.57 to 0.61) and flow factor (ff) is 1.25.The technical support specialist (tss) informed the customer that the ff was too fast.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of hba1c patient results.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 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: 7405375
• MDR Text Key: 105184704
• Report Number: 8031673-2018-00269
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: 04/06/2018
• Distributor Facility Aware Date: 03/08/2018
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/06/2018
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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