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 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) followed-up over-the-phone and confirmed that the customer had gotten the old peek tubing to stop leaking.The fse walked the customer through replacing the old peek tubing with the new that was sent by technical support.The customer indicated that the pressure was at 8.7 mpa (`6-9 ideal pressure) with no leaks.The customer ran quality controls without any issues.The g8 instrument was performing within manufacturer's specifications; no further action was required by the fse.A (b)(6) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2016 through aware date (b)(6) 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 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 leak was due to a loose connection between the peek tubing and the filter housing on the g8 instrument.(b)(4).

Event Description

On (b)(6) 2018, a customer reported a leak coming from the filter housing on the g8 instrument.The customer then reported that the leak had been fixed; however, the black connector was cracked probably because of over tightening.The technical support specialist ordered new peek tubing for the line filter for the customer.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: 7447721
• MDR Text Key: 106847911
• Report Number: 8031673-2018-00331
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 04/20/2018
• Distributor Facility Aware Date: 03/23/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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