MAUDE Adverse Event Report: WB; WESTERN BLOT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Neuropathy (1983); Immunodeficiency (2156); Arthralgia (2355); Disability (2371); Cognitive Changes (2551)

Event Date 11/20/2014

Event Type  Injury  

Event Description

I was ill for 25 years with peripheral neuropathy, migrating joint and tendon problems, cognitive issues, and immune deficiency.I was told by many providers, including the (b)(6) clinic, that it looks like i have lyme, but that i could not , as the elisa and wb were negative.In 2010, i was tested at (b)(6) and was positive by cdc standards, though (b)(6) was still negative.Further tests revealed i was positive for babesia by (b)(6), ehrlichiosis, (b)(6), and i was treated with appropriate antibiotics for the first time.After one year of antibiotics, i became more well than i had been in over 15-20 years.I feel the testing by elisa and wb as currently provided by standard labs and put forward by cdc as a standard kept me sick for over a decade, including disabled from work for 3 years.I am now back to work, but still struggle with ongoing issues from severe autonomic neuropathy and pituitary/adrenal failure.I was definitely hurt.

• Brand Name: WB
• Type of Device: WESTERN BLOT
• MDR Report Key: 4280560
• MDR Text Key: 5293088
• Report Number: MW5039276
• Device Sequence Number: 1
• Product Code: LSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/20/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 57