MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Device Operational Issue (2914)

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

Event Date 06/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under (b)(4).Device by manufacturer: on 15-jun-2015, an fse was dispatched to the customer facility to address the reported event.Fse began to troubleshoot the issue.Fse verified error and replaced defective rheodyne valve, installed new small syringe due to leak, and a new sample needle.Customer had a side vented sample needle that they received from tosoh tech support.Fse replaced tubing from injection valve to large syringe.The g7 controls are within specification and total area is normal.The customer ran quality control (qc) in which all results were within acceptable range and verified that the analyzer was functioning correctly.The g7 analyzer was functioning as intended and the errors cleared.No further action required by field service.The most probable cause of the reported event was due to a defective rheodyne valve.

Event Description

On (b)(6) 2015, a customer reported a defective rheodyne valve with their g7 analyzer.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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 (MANUFACTURER); 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: 7372134
• MDR Text Key: 103831496
• Report Number: 8031673-2018-04126
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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: G7: 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: 03/26/2018
• Distributor Facility Aware Date: 06/12/2015
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/26/2018
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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