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 12/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Fse was able to confirm and reproduce the reported event by running patient samples.Fse reset the pump flow rate from 0.85 ml/min to 1.05 ml/ min, flushed the sampling needle, cleaned and lubricated the sample arm, and then reseated the connection to the column and peek tubing.Fse was subsequently able to run precision and qc without errors.No further issues were noted.No further action was required by fse.The device was installed at the site on 16aug2018.A complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 16aug2018 through aware date (b)(4) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 1- introduction applications, states the following: chapter 1: introduction and applications: 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 reported event was due to the device requiring flow rate adjustment.

Event Description

The customer called to report that retention times (rt) for quality control (qc) were running slow (0.54 minutes) and they received no results with their g8 analyzer.The column count was 606 injections, filter count 66, and pressure 7.6 megapascals (mpa).Technical support (ts) instructed the customer to adjust the flow rate from 1.01 ml/ min to 0.95 ml/ min.Next, the customer ran a few samples; rt was 0.60 ml/min.The customer then ran controls.Rt was 0.56 with no results.The customer requested service.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.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.

• 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: 8240601
• MDR Text Key: 134334998
• Report Number: 8031673-2018-05429
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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: 02/12/2019
• Distributor Facility Aware Date: 01/31/2019
• Device Age: 10 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/12/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1