QUICKVUE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-06 for QUICKVUE * manufactured by *.

Event Text Entries

[228458] A series of pts presented to office with pharyngitis. Dr performed simultaneous quikstrep (with quikvue) and standard throat cultures. In all cases the quickvue came back negative, but cultures grew out heavy growth of group a strep.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022339
• MDR Report Key: 341111
• Date Received: 2001-07-06
• Date of Report: 2001-07-05
• Date Added to Maude: 2001-07-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: QUICKVUE
• Generic Name: QUICK STREPANTIGEN DEVICE
• Product Code: GTY
• Date Received: 2001-07-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 330438
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-07-06