CHOLESTRAK HOME CHOLESTEROL TEST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-01 for CHOLESTRAK HOME CHOLESTEROL TEST * manufactured by *.

Event Text Entries

[451254] Re: home cholesterol tests. This is not serious for me but may be misleading or harmful for others. I've used the cholestrak test several times and the biosafe test as well. I've suspected both were inaccurate lately - cholestrak low, biosafe high. I set up a lab test for cholesterol -total, hdl, ldl, triglycerides, vldl- through a laboratory services. They referred me to a local office to have blood drawn. Sample was tested at another lab and results sent to me and/or my dr at my option. Had purchased a cholestrak test and a biosafe kit to test against the lab test. -biosafe is a lab test but you collect the blood yourself at home through a finger stick, place three drops on a card and send it in-. As suspected, cholestrak result was 30 points low, biosafe 30 points high -details below-. There was less than 1 hour between the lab test collection and the home kits collection - same fasting period, no food consumption. My conclusion is these home tests seem fairly accurate sometimes without verification but obviously are sometimes way off. That's not helpful. I did follow instructions carefully. I'm sure these kits have been tested thoroughly but maybe there is a flaw in some kits the mfr should know about. My conclusion assumes the lab test with the blood drawn through the vein -the same type of test a dr would order- renders the most precise result.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1036241
• MDR Report Key: 697756
• Date Received: 2006-04-01
• Date of Report: 2006-04-01
• Date of Event: 2006-03-20
• Date Added to Maude: 2006-04-12
• 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: 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 HOME CHOLESTEROL TEST
• Generic Name: CHOLESTRAK HOME CHOLESTEROL TEST
• Product Code: NFX
• Date Received: 2006-04-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 686844
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: BIOSAFE CHOLESTEROL TEST
• Generic Name: BIOSAFE CHOLESTEROL TEST
• Product Code: NFX
• Date Received: 2006-04-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 686847
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-04-01