MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. G7

Model Number G7

Device Problem Pressure Problem (3012)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched on (b)(6) 2016.The fse changed peek tubing from i-6 to line filter.The pressure is back to normal.The fse replaced the bent sample needle and changed uptake values.The total area running is in range.No further action required by field service.The g7 analyzer is functioning as intended with all errors cleared.The most probable cause of the reported event was the pump unit, 1-6 peek tubing fault of failure.This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2016 a customer reported high pressure after the column-waste line is backing up with the g7 analyzer.The customer is unable to run prl, bhcg, lh, fsh, e2 and hba1c.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting prl, bhcg, lh, fsh, e2 and 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 BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (MANUFACTURER); 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7387862
• MDR Text Key: 104270385
• Report Number: 3005529799-2018-05009
• 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: 04/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2018
• 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?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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