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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) found the large syringe lead screw and pole dirty.The fse cleaned and lubricated the lead screw and pole of the large syringe.The fse then re-set the aia-360 instrument and the large syringe could move without producing any errors.During warm up of the instrument, the fse got a 101 pressure low error message.The customer confirmed that the error have been occurring intermittently for a while.The fse replaced the vacuum pump, but the problem persisted.The fse then proceeded to replace the 3 elution buffers 2-way solenoid valves and instrument ran without any pressure issues.The fse ran calibration and quality controls, and precision; all passed.The aia-360 instrument was operating within specifications; no further action was required by the fse.A (b)(4) complaint history review and service history review for similar complaints was performed for serial number 13794801 from (b)(4) 2016 through aware date (b)(4) 2018.There were two (2) similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 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.The 706 syringe-l error: explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.The 101 pressure low: the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve.If the elution buffer is empty, place a new elution buffer and execute reagent change.Next, execute drain flush.See "chapter 5 section 5.5: pump air removal".Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times.If the pressure rises when the drain valve is closed, the operation is complete.If the pressure still does not rise or stabilize, execute drain flush again.In addition, confirm that the drain valve is securely closed.The most probable cause of the 706 syringe-l error message was due to a dirty lead screw.The most probable cause of the 101 low pressure error message was due to faulty 2-way solenoid valves.(b)(4).

Event Description

On (b)(6) 2018, a customer reported getting 706 syringe-l error messages upon start-up on the g8 instrument.The technical support specialist instructed the customer to remove the center black cover and perform a sample reset.The customer stated that the sample needle assembly moved front to back, then upon descending into the sample well it did not move.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

Device evaluation by manufacturer: the vacuum pump and three (3) 2-way solenoid valves were returned to tosoh instrument service center (isc) for investigation.The returned parts passed functional testing without any errors.The reported event could not be duplicated.The most probable cause of the 706 syringe-l error and 101 low pressure error messages could not be determined.The vacuum pump and 2-way solenoid valves passed functional testing during the in-house investigation.For corrected data, please refer to the following sections: pma/510(k).Device evaluation by manufacturer: in the initial report the device description was incorrectly reported as aia-360 instrument.The correct device description is as follow: on 23-mar-2018, a field service engineer (fse) found the large syringe lead screw and pole dirty.The fse cleaned and lubricated the lead screw and pole of the large syringe.The fse then re-set the g8 instrument and the large syringe could move without producing any errors.During warm up of the instrument, the fse got a 101 pressure low error message.The customer confirmed that the error have been occurring intermittently for a while.The fse replaced the vacuum pump, but the problem persisted.The fse then proceeded to replace the 3 elution buffers 2-way solenoid valves and instrument ran without any pressure issues.The fse ran calibration and quality controls, and precision; all passed.The g8 instrument was operating within specifications; no further action was required by the fse.Event problem and evaluation codes (refer to coding manual): result code(s): 213, conclusion code(s): 4315.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.

Event Description

N/a.

Manufacturer Narrative

Device evaluated by mfr.The returned parts were unable to be located by the instrument service center (isc); therefore, further evaluation could not be performed.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 105-8 623; JA 105-8623
• MDR Report Key: 7445751
• MDR Text Key: 106616766
• Report Number: 8031673-2018-00328
• 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: 02/06/2019

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: 01/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2019
• Distributor Facility Aware Date: 01/21/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 01/21/2019
• Supplement Dates FDA Received: 11/22/2018; 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1