CLEARVIEW FLU A/B * 6340KCV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-13 for CLEARVIEW FLU A/B * 6340KCV manufactured by Wample Laboratories.

Event Text Entries

[19489723] Twenty eight percent negative results for rapid influenzae a/b test kit between 10/04 and 2/15/2005. Company notified by our lab and replied that this was due to "bad lot. " replacement kit results were 33% false negatives between 2/16/2005 and 04/2005. Physicians use test to make diagnosis and treatment decisions. Product literature claims 92% sensitivity/100% specificity.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1036614
• MDR Report Key: 748942
• Date Received: 2005-09-13
• Date of Report: 2005-09-13
• Date Added to Maude: 2006-08-16
• 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: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CLEARVIEW FLU A/B
• Generic Name: RAPID INFLUENZAE TEST KIT
• Product Code: GRP
• Date Received: 2005-09-13
• Model Number: *
• Catalog Number: 6340KCV
• Lot Number: 79261
• ID Number: *
• Device Expiration Date: 2005-06-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 736723
• Manufacturer: WAMPLE LABORATORIES
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Device Sequence Number: 2

• Brand Name: CLEARVIEW FLU A/B
• Generic Name: RAPID INFLUENZAE TEST KIT
• Product Code: GRP
• Date Received: 2005-09-13
• Model Number: *
• Catalog Number: 6340KCV
• Lot Number: 80125
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 743155
• Manufacturer: WAMPLE LABORATORIES
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Device Sequence Number: 3

• Brand Name: CLEARVIEW FLU A/B
• Generic Name: RAPID INFLUENZAE TEST KIT
• Product Code: GRP
• Date Received: 2005-09-13
• Model Number: *
• Catalog Number: 6340KCV
• Lot Number: 82435
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 743157
• Manufacturer: WAMPLE LABORATORIES
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-09-13