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

Model Number G8

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineer (fse) conducted a service call with the customer to address the reported event.During troubleshooting, the customer verified the issue.Fse ordered a sample loop and the customer installed the sample loop.After the installation of the sample loop, the customer calibrated the instrument and the quality controls were within the acceptable range.The instrument was running 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 for serial number (b)(4) and biorad control 33952 from 30-apr-2017 through aware date 30-may2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and application, 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.Qc materials should be used in accordance with local, state, federal and accredited organizations.The most probable cause of the reported event was due to a bad sample loop.

Event Description

A customer reported that the biorad (br) quality control (qc) was out high on lot 33952 while running quality controls on the g8 instrument.The glycosylated hemoglobin (sa1c) retention time (rt) was 0.62 minutes.Technical support (ts) had the customer to adjust the flow factor (ff) from 1.07 ml/min to 1.09 ml/min and then recalibrate and repeat quality control.The br 33952 results were 10.1% and 9.9%.The customer called the next day and reported that the br control level 2 was still running 9.8-9.9%.The customer stated that after calibration, the level 2 controls were running around 10.0% and before that the result was 9.5%.The customer had already recalibrated the instrument four times but the levels were still out high.The customer was within the target range of 8.63-10.55%.Ts sent the customer calibrator and tosoh controls.Field service engineer (fse) was dispatched to address the reported event, which resulted in delay in 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.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; 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: 7602878
• MDR Text Key: 112159295
• Report Number: 8031673-2018-00555
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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: 06/14/2018
• Distributor Facility Aware Date: 05/30/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/14/2018
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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