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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer followed-up over-the-phone and instructed the customer to inspect the tubing for clogging and then place the feed tube from the elution buffer 1 into the hemolysis wash solution and pump through the instrument for five (5) minutes or more to dissolve the clog.Then wipe off the feed tube and replace with the elution buffer 1 again pumping for five (5) or more minutes.The g8 was operating within specifications.On (b)(6) 2018, the customer reported that the 100 high pressure error message persisted.The fse followed-up over-the-phone and was going to have the customer repeat the procedure, but the customer stated that the g8 instrument was operating as intended.The fse advised the customer to repeat the flushing procedure after the runs were done at the end of the day as a precaution.The g8 was performing within manufacturer's specifications; no further action was required by the fse.A 13-month complaint history review and service history review for serial number (b)(4) from 16-feb-2017 through aware date 16-mar-2018 for similar complaints was performed.There were four (4) 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: 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.The most probable cause of the reported 100 high pressure error message was due to a clogged tubing.(b)(4).

Event Description

On (b)(6) 2018, a customer reported getting 100 high pressure error message on the g8 instrument.Prior to contacting tosoh technical support the customer had replaced the filter.The customer verified that the filter was seated correctly with the lighter side down.The technical support specialist (tss) walked the customer through several troubleshooting steps in attempts to resolve the 100 high pressure error message, but the issue persisted.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.

• 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: 7431910
• MDR Text Key: 105659536
• Report Number: 8031673-2018-00308
• 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: 09/19/2018

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2018
• Distributor Facility Aware Date: 09/18/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/15/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1