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 12/19/2018

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 confirmed and reproduced the issue by running quality controls (qc).Fse replaced the stator seal, rotor seal, and the sample loop.Fse then ran qc diluted with wash and water and the level 2 qc result was in range.The results from the diluted qc were: level 1-5.1%, 5.0%, 5.0%; level 2-9.6%, 9.7%, 9.7%.The instrument was operating as expected.A periodic maintenance (pm) was performed without any issues.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed on serial number (b)(4) from 19-nov-2017 through aware date (b)(4) 2018.There were no similar complaints 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 has not yet been determined.The investigation is in progress.

Event Description

A customer reported that the quality controls (qc) were recovering high on the g8 instrument.The level 2 qc results were 10.0% and 10.1% (range of 9.7-9.9%).The level 1 qc result was 5.2% (range 4.9-5.3%).The qc was high at 9.9% that day and the day before.The customer repeated with fresh qc after recalibrating and the results were still high.The column count was 445 injections and the injection count was 19,745.The column was changed out the day before and the high results occurred on the new and old columns.The customer requested a periodic maintenance (pm) since their injections were almost to 20,000.The instrument was down.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.Device evaluation by manufacturer: the rotor seal, sample loop, and stator face assembly were returned for evaluation.Functional testing was performed by running a 10-sample precision test on all parts and results for each part were within range.The parts passed testing.The reported problem could not be duplicated.The most probable cause of the reported problem could not be determined.

• 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: 8229662
• MDR Text Key: 133868093
• Report Number: 8031673-2018-05419
• 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: 02/05/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/30/2019
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1