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

Model Number G8

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Fse followed up with the customer via telephone to address the reported event.Inspection of the device by the customer revealed that there was another machine on top of the waste tube impeding the waste flow.The customer adjusted the waste tube so that there were no restrictions and the waste started to flow again.Next, the customer ran quality control (qc) and four patient samples successfully, and with no leaking.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6)2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual, under chapter 2- connections, states the following: 2.5 connections: waste tube insert the waste tube firmly into the waste port located on the bottom of the main unit.(refer to fig.2-5) securely tighten the waste tube with the bandage provided in the accessory box.Insert the other end of the tube to the waste bottle.(refer to fig.2-6) note if the waste tube is bent, the waste eluent may not drain out smoothly.Adjust (cut) the tube length to keep the tube end above the waste eluent level.When changing the analyzer location, make sure that the tube is not loose, broken or bent and that the waste eluent drains out smoothly.The sample loader must also be temporarily disconnected when changing the analyzer location.If the waste tube is bent and waste eluent cannot smoothly drain, the sample dilution may not be accurately executed during the assay.Do not try to pick up or move the tube.Keep the waste tube end above the top of the waste eluent.The most probable cause of the reported event is due to operator error.

Event Description

It was reported that the g8 analyzer was leaking after being moved down the hall.The customer stated that the analyzer rolled over the waste tubing and that possibly the waste tubing or the black plug had disconnected.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 was 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
• Manufacturer (Section G): TOSOH CORPORATION; 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: 7707681
• MDR Text Key: 114811735
• Report Number: 8031673-2018-00647
• 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: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2018
• Distributor Facility Aware Date: 06/26/2018
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/20/2018
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2016
• 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