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 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During the evaluation, fse replaced the associated tubing for the injector valve and column.Fse then primed samples several times.The customer ran calibration, quality controls (qc), and sample precision with acceptable results.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed on biorad lot 38550 and serial number (b)(4) from 30-jul-2017 through aware date (b)(6) 2018.There were three similar complaints including the current complaint identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: quality control in order to monitor and evaluate the accuracy and precision of the analytical performance, controls should be assayed daily and after column replacement.Tosoh suggests running at least two levels of quality control material.The mean of one should be in the non-diabetic range (4-7% hba1c) with the second in the range of 9-12% hba1c.If the value of one or more control specimens is out of the acceptable range, recalibrate the system and rerun the controls before testing patient samples.The most probable cause of the reported event was due to failure of the tubing to injector valve and column.

Event Description

A customer reported a shift in the quality control (qc) level 3 results with the g8 instrument.The customer was running biorad (br) lot 38550.The level 3 qc hba1c results were 13.8 % with established values of 13.3-13.7% (target range of 12.18% -14.89 % with a mean of 13.53%).When compared to a second g8 instrument, the qc level 3 value was 13.7% with established values of 13.3-13.7% (target range of 12.18% -14.89 % with a mean of 13.53%).Both instruments had retention times (rt) of 0.60-0.61 minutes.Technical support (ts) observed that the second g8 instrument is only out of range of the established values by 0.1% but both instrument had shifted from the established mean.The customer was instructed to re-establish the ranges but refused.The customer reported that the shipment of qc had been frozen for over a year at -70 but do not believe the issue is the quality controls.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 is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

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.

• 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 10586 23; JA 1058623
• MDR Report Key: 7883927
• MDR Text Key: 120738290
• Report Number: 8031673-2018-00859
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Distributor Facility Aware Date: 10/19/2018
• Device Age: 11 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/25/2018
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1