HOME ACCESS HIV TEST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-05 for HOME ACCESS HIV TEST * manufactured by Home Access Health Corp.

Event Text Entries

[516732] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1036516
MDR Report Key746549
Date Received2005-09-05
Date of Report2005-09-05
Date of Event2005-05-11
Date Added to Maude2006-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHOME ACCESS HIV TEST
Generic NameHIV TEST
Product CodeMVZ
Date Received2005-09-05
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key734348
ManufacturerHOME ACCESS HEALTH CORP
Manufacturer Address2401 WEST, HASSEL RD STE #1510 HOFFMAN ESTATES IL 60195 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-09-05

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