VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) 20-006-021 20-005-021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) 20-006-021 20-005-021 manufactured by Nanosphere, Inc..

MAUDE Entry Details

• Report Number: 3006028115-2019-00002
• MDR Report Key: 9363438
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-11-22
• Date of Report: 2019-11-21
• Date of Event: 2019-10-09
• Date Mfgr Received: 2019-10-25
• Device Manufacturer Date: 2019-08-02
• Date Added to Maude: 2019-11-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. WENDY RICKER
• Manufacturer Street: 1224 DEMING WAY
• Manufacturer City: MADISON WI 53717
• Manufacturer Country: US
• Manufacturer Postal: 53717
• Manufacturer Phone: 6082038936
• Manufacturer G1: NANOSPHERE, INC.
• Manufacturer Street: 4088 COMMERCIAL AVENUE
• Manufacturer City: NORTHBROOK IL 60062
• Manufacturer Country: US
• Manufacturer Postal Code: 60062
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)
• Generic Name: GRAM-NEGATIVE BLOOD CULTURE TEST
• Product Code: PEN
• Date Received: 2019-11-22
• Model Number: 20-006-021
• Catalog Number: 20-005-021
• Lot Number: 080219021A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NANOSPHERE, INC.
• Manufacturer Address: 4088 COMMERCIAL AVE. NORTHBROOK IL 60062 US 60062

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2019-11-22