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

Model Number G8

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, 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.On 11-november-2016, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the sample needle and verified alignments to the tube.The fse also lubricated the mechanical system.The g8 instrument is operational.No further action is required by field service.The most probable cause for the reported event was the sample needle.

Event Description

On (b)(6) 2016, a customer reported a bent sample needle on the g8 instrument.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(6) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for 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-723GA ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 7387144
• MDR Text Key: 104260309
• Report Number: 8031673-2018-04368
• 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
• Report Date: 03/30/2018

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Distributor Facility Aware Date: 11/11/2016
• Device Age: 12 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1