FDA Adverse Event Malfunction Summary report: N

HOME ACCESS HIV TEST

MDR report key: 746549 · Received September 5, 2005

Report

Report Number
MW1036516
Event Type
Malfunction
Date Received
September 5, 2005
Date of Event
May 11, 2005
Report Date
September 5, 2005
Manufacturer
HOME ACCESS HEALTH CORP
Product Code
MVZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM EXTREMELY DISAPPOINTED WITH THE FAILURE AND NON-PERFORMANCE OF MY HOME ACCESS HEALTH CORP HIV TEST. MY TEST, WHEN MAILED IN, PROVED TO BE DEFECTIVE AND THE TEST RESULTS INVALID. I HAVE CONTACTED THE MFR AND REQUESTED A REFUND BUT THEIR CUSTOMER SERVICE ATTITUDE IS UNCOOPERATIVE AND THEY HAVE REFUSED TO WORK WITH ME AT ALL, EVEN THOUGH THE PRODUCT WAS NON-FUNCTIONAL. TO BRIEFLY EXPLAIN THE SITUATION: I HAVE TICK CALLUSES ON MY HANDS WHICH MADE IT IMPOSSIBLE TO DRAW A SUFFICIENT AMOUNT OF BLOOD USING THE MFR'S FLIMSY AND SUBSTANDARD LANCETS, DESPITE THE FACT THAT I FOLLOWED ALL INSTRUCTIONS INCLUDED WITH THE TEST. THE FIRST OF THE INCLUDED LANCETS DID NOT EVEN FULLY PIERCE MY SKIN; THE SECOND BARELY PIERCED THE SKIN AND DREW ONLY A TINY AMOUNT OF BLOOD. WHEN I CALLED HOME ACCESS CORP'S 1-800 NUMBER TO ASK IF I MIGHT INSTEAD BE ABLE TO DRAW BLOOD FROM MY TOES OR ELSEWHERE, THEIR REP WAS VERY VAGUE AND EVASIVE, AND WOULD NOT PROVIDE DEFINITE ANSWERS TO THE QUESTIONS OF WHETHER I COULD DRAW BLOOD ELSEWHERE. THEN, THE TEST RESULTS CAME IN AS, "INCOMPLETE" DUE TO CLOTTING, WHICH THEY HAVE ADVISED ME IS A COMMON RESULT OF NOT BEING ABLE TO DRAW ENOUGH BLOOD. WHEN I RECEIVED THESE RESULTS, THE HOME ACCESS AGENT ON THE PHONE WAS EXTREMELY HOSTILE AND RUDE TO THE POINT OF BEING BLATANTLY INSULTING AND OFFENSIVE. SHE ESSENTIALLY SHOUTED AT ME THAT I HAD NOT FOLLOWED DIRECTIONS AND THEN REFUSED TO PROVIDE ME A REPLACEMENT TEST OR ANSWER FURTHER QUESTIONS. WHEN I ASKED TO SPEAK TO A SUPERVISOR, SHE HUNG UP ON ME. I STILL HAVE NOT RECEIVED ANY SATISFACTORY RESULTS FROM THIS PRODUCT, AND I AM OUTRAGED AT THE UNPROFESSIONAL AND OFFENSIVE CONDUCT OF HOME ACCESS AND THEIR EMPLOYEES. I FEEL THAT THE FDA SHOULD BE AWARE OF THE POOR PRODUCT QUALITY AND BLATANT ABUSE OF CUSTOMERS THAT IS BEING PRACTICED BY THIS PRODUCT'S MFR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOME ACCESS HIV TEST HIV TEST MVZ HOME ACCESS HEALTH CORP * *

Patients

Seq Age Sex Outcome Treatment
1 30 YR