FDA Adverse Event Malfunction Summary report: N

CHOLESTRAK HOME CHOLESTEROL TEST

MDR report key: 697756 · Received April 1, 2006

Report

Report Number
MW1036241
Event Type
Malfunction
Date Received
April 1, 2006
Date of Event
March 20, 2006
Report Date
April 1, 2006
Manufacturer
*
Product Code
NFX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CHOLESTRAK HOME CHOLESTEROL TEST CHOLESTRAK HOME CHOLESTEROL TEST NFX * * *
2 BIOSAFE CHOLESTEROL TEST BIOSAFE CHOLESTEROL TEST NFX * * *

Patients

Seq Age Sex Outcome Treatment
1 44 YR