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 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 09-feb-2018 through aware date 09-mar-2018.There were five (5) 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 most probable cause of the fast retention time could not be determined.(b)(4).

Event Description

On (b)(6) 2018, a customer reported seeing fast retention time of 0.62 minutes (acceptable range is 0.57 to 0.61 minutes) with two (2) patient samples on the g8 instrument.The customer confirmed that the current retention time was within acceptable range; therefore, there was no need for flow factor adjustment.It is not known whether hemoglobin a1c results were impacted due to the out of range retention time.There is no indication of any patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

Event Description

On (b)(6) 2018, a customer reported seeing fast retention time of 0.62 minutes (acceptable range is 0.57 to 0.61 minutes) with two (2) patient samples on the g8 instrument.Technical support (ts) confirmed that the current retention time was within acceptable range; therefore, there was no need for flow factor adjustment.It is not known whether hemoglobin a1c results were impacted due to the out of range retention time.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 105-8 623; JA 105-8623
• MDR Report Key: 7405581
• MDR Text Key: 105248023
• Report Number: 8031673-2018-00276
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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: 09/14/2018
• Distributor Facility Aware Date: 08/27/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/07/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1