MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. G7

Model Number G7

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

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

Event Date 05/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On (b)(4) 2015, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the damper unit.The g7 instrument is operational.No further action is required by field service.The most probable cause for the reported event was a defective damper unit.

Event Description

On (b)(6) 2015, a customer reported that the tubing on the left side of the column kept popping out , the br 33880 is recovering low, and the pressure reading was displayed higher than expected while in standby mode on the g7 instrument.Technical support assisted the customer with reinstalling the column and advised the customer to adjust the flow factor.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(4) 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 BIOSCIENCE, INC.; 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE; 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7381203
• MDR Text Key: 104141488
• Report Number: 3005529799-2017-04333
• 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: 03/29/2018

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: 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: 03/29/2018
• Distributor Facility Aware Date: 05/07/2015
• Device Age: 14 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2002
• 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