CHOLESTRAK * 80202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-17 for CHOLESTRAK * 80202 manufactured by Accutech Llc.

Event Text Entries

[476444] The test kit repackaged by accutech llc as cholestrak -and other repackagers- has been giving errorneous results for the past 2 years. Since heart disease is the number one killer of americans and since the results are always at least 40 points too low, i am reporting this as a life-threatening situation for all those who use this product and believe the results based on the fda approval of this product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038311
• MDR Report Key: 695597
• Date Received: 2006-03-17
• Date of Report: 2006-03-17
• Date Added to Maude: 2006-04-06
• 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: PATIENT
• 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 Sequence Number: 1

• Brand Name: CHOLESTRAK
• Generic Name: *
• Product Code: NFX
• Date Received: 2006-03-17
• Model Number: *
• Catalog Number: 80202
• Lot Number: 05P0476
• ID Number: *
• Device Expiration Date: 2007-05-01
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 684716
• Manufacturer: ACCUTECH LLC
• Manufacturer Address: 2641 LA MIRADA DR VISTA CA 92081 US

Device Sequence Number: 2

• Brand Name: INSTANT CHOLESTEROL TEST
• Generic Name: *
• Product Code: NFX
• Date Received: 2006-03-17
• Model Number: *
• Catalog Number: *
• Lot Number: 04P0404
• ID Number: *
• Device Expiration Date: 2006-10-31
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 684724
• Manufacturer: HOME ACCESS HEALTH CORP.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2006-03-17