MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8; G8, PRODUCT CODE: LCP

Model Number G8

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under (b)(4).The field service engineer (fse) was dispatched on 21 december 2015.The fse had the customer inspect instrument for leaks and none were found.Fse had her do a drain flush to get rid of any air in the lines.The g8 was working as intended.No further action required by fse.The probable cause of the event was air in the tubing.

Event Description

On (b)(6) 2015 a customer reported patient recovery with their g8 analyzer.The customer reported that a physician questioned a lab result which he received from (b)(6) 2015.This specimen was sent out as 6.5%.Reportedly the specimen was rerun on (b)(6) 2015 with a result of 7.3%.Technical services was told that this same patient had a ha1c done on (b)(6) 2015 that was reported out as 7.5%, which resulted in the doctor questioning the 6.5 result.A field service engineer (fse) was dispatched to address the reported event.There was no indication of any patient intervention or adverse event consequence due to the alleged discrepant patient results.

Manufacturer Narrative

This mdr is a duplicate of mdr 3005529799-2015-00013; and therefore, was submitted in error.(b)(4), per exemption number e2017013.This report is being submitted due to a retrospective review conducted under capa-2017-0007.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, PRODUCT CODE: LCP
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 7315187
• MDR Text Key: 101851212
• Report Number: 8031673-2018-01439
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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: 04/16/2018
• Distributor Facility Aware Date: 12/21/2015
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/16/2018
• Date Manufacturer Received: 12/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1