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

Model Number G8

Device Problems Mechanical Problem (1384); Failure to Align (2522); Noise, Audible (3273)

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

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During evaluation, the fse confirmed a bent needle, high pressure and leak at the filter holder in the instrument.Fse also confirmed z1-axis error and a large syringe error in the error log.Fse replaced the bent needle and then made an adjustment to the y-axis sampling to sample loader.Fse found thick layers of labels below the base of the tube causing the tube to sit in the rack to one side and the needle to hit the hard plastic on the cap.This is what led to z1-axis error and the bent needle.Fse also found that the filter was in backwards and replaced the filter.Fse provided instructions to the customer on how to properly install the filter.The pressure on the instrument was 13 mpa.Fse replaced the peek tubing to get a normal pressure of 8.0 mpa.Fse found that the large syringe was very tight although it had a worn tip.Fse replaced the large syringe.Calibration and quality controls (qc) were run with acceptable results.The customer ran patient samples without any issue.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 for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were three (3) similar complaints including this complaint identified during the searched period.Under chapter 5 maintenance procedures, 5.10 sampling needle replacement has a caution that states the following: replace the sampling needle if it is bent or broken.Use the following procedure to replace the sampling needle.Access to the inside of the analyzer is needed to replace the sampling needle.Be sure that only personnel who have been trained by tosoh or its representatives perform these operations.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Take care not to touch the end of the sampling needle during handling.If the needle placement is clearly off center of the primary tube, it must be adjusted.Cancel the assay and contact technical support.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting states the following: 6.3 error messages when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages with these errors, the assay stops and the analyzer immediately enters stand-by state.100 pressure high the pump pressure exceeded the upper limit (15 mpa) set in the pres high parameters.When the filter or column replacement period has been exceeded, first replace the filter or column.If the pressure is still high, remove the inlet and outlet flow line around the column and filter, and determine which part is the cause of the high pressure.Then, contact a technical support representative.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.710 z1-axis error an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.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 sample needle was not consistently hitting the center of the cap on the tube on the g8 instrument.The customer verified that the sample needle was secure and the tubes were not moving in the racks.Additionally, the customer reported that the tubes were not consistently dropping back into the rack when the needle lifted up.The customer was also concerned that the labels might be an issue on occasion.Technical support (ts) instructed the customer to reboot the instrument but when they did, the customer reported hearing a grinding noise.Ts instructed the customer to clean the guide rods but the customer could not reach the spiral guide rod.The customer did not have an additional sample needle to use for replacement and stated that they preferred not to run the instrument without any caps.The instrument was down.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 sample needle assembly was received for evaluation.Visual inspection revealed a bend in the needle and a deformed piercing tip.The reported product problem was confirmed and the error could be duplicated.The part failed visual inspection.Evaluation codes: method: 10 testing of actual/suspected device; 4109 historical data analysis; results: 3211 deformation problem; conclusion code: 4307 cause traced to component failure.The most probable cause of the reported event was due to bent sample needle with a deformed piercing tip.

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.The large syringe and a periodic maintenance (pm) kit (containing peek tubing lines, rheodyne rotor and stator, 6-way valve, and 2 filter stones) were returned for evaluation on 16-oct-2018.The large syringe was visually evaluated and a large crack was found going up the barrel of the syringe.The part failed visual inspection.Functional testing could not be performed on a physically damaged part.The reported problem with the large syringe was confirmed.All parts of the pm kit were tested and found functional.The parts passed testing.The reported event could not be duplicated.

• 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: 7988244
• MDR Text Key: 126226604
• Report Number: 8031673-2018-00937
• 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,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2019
• Distributor Facility Aware Date: 12/08/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/04/2019
• Date Manufacturer Received: 12/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1