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 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer followed-up over-the-phone and instructed the customer to tighten the connections to the filter housing.The customer reported that there was no leak after tightening the connections.The g8 was performing within manufacturer's specifications; no further action was required by the fse.A (b)(4) complaint history review and service history review for serial number (b)(4) from (b)(4) 2017 through aware date (b)(4) 2018 for similar complaints was performed.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 5, maintenance procedures, states that when replacing the filter to ensure that there are no leaks from the filter housing components and tube connections.If a leak is found, tighten the assembly further.The most probable cause of the reported issue was due to a loose connection to the filter housing.(b)(4).

Event Description

On (b)(6) 2018, a customer reported seeing a leak near the column from the tubing line that is coming from inside the instrument and into the filter housing on the g8 instrument.The leak was occurring near the column oven; the aluminum block has build-up of precipitate.The technical support specialist (tss) instructed the customer to detach the line to see if the connection was loose, but the customer was not able to detach it.The customer reported that the leak had been happening for about two (2) weeks.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.

• 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
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7445001
• MDR Text Key: 106650316
• Report Number: 8031673-2018-00319
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2018
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1