MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).The customer subsequently decided to upgrade to a g8 analyzer.No further action was required.The most probable cause for the reported event remains unresolved as the customer declined service and decided to upgrade to a new device.

Event Description

On (b)(6) 2015, the customer reported controls consistently running on the high end of the range, and an increase in retention times with their g7 analyzer.Technical support (ts) advised the customer to fax chromatograms, adjust the flow factor (ff), and make fresh quality control (qc).The changes were unsuccessful in resolving the control recovery.On (b)(6) 2015, ts reviewed faxed peer data and advised the site to perform preventative maintenance (pm) after noting the customer means to be higher than the peer data.On (b)(6) 2015 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: G7
• Type of Device: G7
• 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 94080 ; 6506368123
• MDR Report Key: 7339317
• MDR Text Key: 102595790
• Report Number: 8031673-2018-02447
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011434
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: 019327
• 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: 03/14/2018
• Distributor Facility Aware Date: 05/13/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/14/2018
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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