VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-06-28 for VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux Inc..

MAUDE Entry Details

• Report Number: 1950204-2019-00219
• MDR Report Key: 8745175
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-06-28
• Date of Report: 2019-09-19
• Date Mfgr Received: 2019-08-27
• Device Manufacturer Date: 2018-11-30
• Date Added to Maude: 2019-06-28
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JEFF SCANLAN
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: HAXELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3147318694
• Manufacturer G1: BIOMERIEUX INC.
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: SAINT LOUIS MO 63042
• Manufacturer Country: US
• Manufacturer Postal Code: 63042
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
• Generic Name: VITEK? 2 GN ID TEST KIT
• Product Code: LQM
• Date Received: 2019-06-28
• Catalog Number: 21341
• Lot Number: 2410734103
• Device Expiration Date: 2019-11-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMERIEUX INC.
• Manufacturer Address: 595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-28