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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During servicing, fse replaced the tube for the injection valve to the line filter.Fse used customer pipettes to reconstitute quality controls.Fse then adjusted the flow rate from 1.16 ml/min to 1.10 ml/min to get retention time (rt) of 0.59 minutes.Rt range = 0.57 to 0.61 minutes.Fse ran precision tests and passed with results %coefficient of variation (cv)= 0%.Range: %cv=/<2%.Fse then ran quality controls with acceptable results.The g8 instrument was working as designed.No further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 14-apr-2017 through aware date 14-may-2018.There were no similar complaints found.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.A 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: greater than the pressure on the column inspection report + 4 mpa, then replace the filter.Less than the pressure on the column inspection report, then proceed with priming the column.150 grad sensor error: this error indicates that the grad sensor on the pump malfunctioned.The error can be counter measured by checking the grad sensor.The most probable cause of the reported event was due to clogged line from the injector valve to the filter line.Additionally, the flow rate needed to be adjusted.

Event Description

The customer reported error 100 pressure high and 150 grad sensor errors on the g8 instrument.The column count (cc) was 2019 and the filter count (fc) was 273.Technical support specialist (tss) advised the customer to change the filter and the pressure alarm went off.Tss then instructed the customer to remove the filter and hit pump but the pressure alarm went off again.The customer has other g8 instruments.Field service engineer (fse) was dispatched to address the reported event.The event was likely to cause discrepant 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

(b)(4), 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.Correction: field service engineer (fse) was dispatched to address the reported event, which resulted in delay 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.Device evaluation by manufacturer: the rheodyne i6 line was received for evaluation on 23-may-2018.Functional testing was performed and found a clog in the rheodyne line.The line failed to transfer fluid from the rheodyne valve to the filter assembly.The reported 100 pressure high error message was duplicated.Evaluation codes: method code: 89 flow testing.Conclusion code: 13 device difficult to operate.

Event Description

Field service engineer (fse) was dispatched to address the reported event, which resulted in delay 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.

• 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: 7551610
• MDR Text Key: 110385860
• Report Number: 8031673-2018-00497
• 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: 07/02/2018

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: 05/23/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2018
• Distributor Facility Aware Date: 05/23/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/02/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1