MAUDE Adverse Event Report: TOSOH CORPORATION G8

Model Number G8

Device Problems Device Issue (2379); Output Problem (3005)

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

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was not dispatched.Tss advised customer to make new bottle of l1 control, therefore, no further action required by field service.The most probable cause of the reported event was due to a degraded control.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On 20-mar-2016, a customer reported p00 peak on l1 qc failure with their g8 analyzer.A field service engineer (fse) was dispatched on 20-mar-2016, the customer to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minata-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: 7374400
• MDR Text Key: 103698789
• Report Number: 8031673-2018-03425
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• 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: 03/27/2018
• Distributor Facility Aware Date: 05/20/2016
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/27/2018
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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