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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse replaced the large syringe, flushed the instrument, replaced stator face and feal for g8 and sample loop and cleared large syringe error.Then the fse replaced the sample needle assembly and received large syringe error 706.On the (b)(6) 2018 the fse returned to continue troubleshooting the instrument and cleaned injection valve, replaced sample loop, stator face and seal for injector valve, replaced rotor seal for 6 way valve.The fse then ran patient sample and recevied ec high pressure.Then fse replaced sample loop, replaced tubing 1-6 (tube from injection valve to line filter) and flushed the instrument.But the error ec100 high pressure still occurred.Fse returned on the (b)(6) 2018 to continue troubleshooting on the instrument and replaced rheodyne valve with plate and replaced sample loop.Fse performed pressure check and the pressure was reading at 7.54 mps.Fse ran patient samples and adjusted the flow factor from 1.07 to 1.01 due to retention time reading at 0.57.The new retention time is set at 0.60.Fse calibrated the instrument and ran quality controls, results were within specifications and without any errors.Instrument is functioning as intended and was released.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the (b)(6) 2017 through awareness date on the (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: general error messages with these errors, the assay stops and the analyzer immediately enter 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.706 syringe-l error explanation: operation error in syringe-l.Countermeasure: inspect syringe-l.Execute smp.Reset.The most probable cause of the reported issue was due to a worn syringe tip for the large syringe errors and an obstructed rheodyne valve.(b)(4).

Event Description

The customer reported receiving error 706 syringe-l error and high pressure on their g8 instrument during start up.The customer changed the filter and the peek was kinked.Customer tried to straighten it out.The column count (cc) is 1900.The technical support specialist (tss) advised the customer to clean the metal assembly at the bottom of the large and small syringe.The small syringe had dirt on it and while viewing the large syringe movement the error 706 occurred.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Device evaluation by manufacturer.The large syringe and rheodyne valve were returned for investigation.Visual inspection of the rheodyne valve shows damage in the back of the part.Functional testing could not be performed on the rheodyne valve due to the part being mechanically damaged.The large syringe functional testing did not confirm the failure and error could not be duplicated.The most probable cause of the reported issue was due to the rheodyne valve.Updated section.Conclusion code: 13 device difficult to operate.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
• 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: 7547254
• MDR Text Key: 109905164
• Report Number: 8031673-2018-00487
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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: 05/21/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Distributor Facility Aware Date: 05/21/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/27/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1