MAUDE Adverse Event Report: TWO-TIER LYME DISEASE TESTING; LYME TEST

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Immunodeficiency (2156); Disability (2371); Inadequate Pain Relief (2388); Cognitive Changes (2551)

Event Type  Injury  

Event Description

I was misdiagnosed for almost a decade due to insufficient knowledge of borreliosis in the medical community.I was tested with the two-tier lyme disease test and was not "positive enough" although i showed antibodies for it.This testing was never fda approved and is not a valid method.The only valid method is described in us patent 5,618,533.I am (b)(6) and struggle to make it through every day.I was finally clinically diagnosed with borreliosis, bartonellosis, and babesiosis by a renowned tick-borne disease doctor with over 30 years of experience.I have been in treatment for 15 months and have seen the most improvement after the 8th month of treatment.I am still no where near better because my immune system has been so compromised that i don't make antibodies to fight these diseases, but also viruses that were latent in my body have reactivated.So, not only do i have 3 different tick-borne illnesses, i also have hvv6, epstein-barr virus, mononucleosis, coxsackie, cognitive dysfunction, severe memory loss, severe muscle, bone, and nerve pain, for which i can't get help treating.I have medical professionals who tell me there is nothing wrong with me.I had a pain management doctor telling me to meditate to relieve my pain.It is absolutely disgusting that i live in the united states of america and i can't get proper health care.I'm at the point right now where i might be on disability for the rest of my life because of the fraudulent testing in place that kept me ill and misdiagnosed and undiagnosed for almost a decade.I'm living in excruciating pain.My body is a torture chamber.Why is this testing in place? it was never fda approved.I don't understand how something so complex as tick-borne disease that causes such immunosuppression that all the other things i've ever been exposed to have reactivated and i'm fighting them all at the same time.Why? why is this occurring? please help fix this issue.These tests are bogus! they are keeping people sick.I could die and a lot of people already have.It's only a matter of time before everyone catches on to this.Please, i urge you, fda, to eliminate this faulty, fraudulent deer born testing.My inflammation markers are 5 times the normal amount.I can't get pain medication or help from mainstream doctors at all.Why is this happening? i live in a borreliosis hot bed in (b)(6).Almost every single person i know has had lyme disease or some tick-borne disease, and many of us have been fighting them for years before being diagnosed.It might be too late for me.No one is immune, so don't wait until you or a loved one is affected by this testing.It will happen.Please, help us all.I have spent over (b)(6) on my health out of pocket in the last year because my insurance company will not pay for my treatment, doctor or medications.

• Brand Name: TWO-TIER LYME DISEASE TESTING
• Type of Device: LYME TEST
• MDR Report Key: 4199114
• MDR Text Key: 15328467
• Report Number: MW5038775
• Device Sequence Number: 1
• Product Code: LSR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 28 YR
• Patient Weight: 50