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

Model Number G8

Device Problems Mechanical Problem (1384); Decrease in Pressure (1490)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse found the tube for the line filter was damaged while attempting to replace the filter and it was replaced.The fse then ran quality controls and all the results were within specification and without any errors.The instrument is functioning as intended and was released.No further actions are required by the fse.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 chapter 6 troubleshooting states the following: 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 reported issue is due to the operator damaging the tubing during replacement of the filter.(b)(4).

Event Description

The customer reported receiving error 101 pressure low on their g8 instrument.Customer indicated that the ferrule that connects into the wing nut of the pre-filter is broken and leaking.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

(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.Device evaluation by manufacturer: the tube for line filter was returned for further evaluation.Functional testing was performed and the tube for line filter passed the testing.The returned part did not confirm the reported event and the error was not duplicated.The most probable cause of the reported issue unknown.Corrected data.

• 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: 7750307
• MDR Text Key: 116064125
• Report Number: 8031673-2018-00743
• 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: 10/15/2018

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: 07/24/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2018
• Distributor Facility Aware Date: 07/24/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/15/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/05/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1