MAUDE Adverse Event Report: LYME TESTING; REAGENT, BORRELIA SEROLOGICAL REAGENT

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Disability (2371); No Code Available (3191)

Event Date 06/01/2009

Event Type  Injury  

Event Description

I was infected with lyme in 2007.Became seriously ill by 2009.Between 2009 and 2016 received 4 lyme tests all negative.In 2013 i became bedridden.Completely disabled.Finally in 2016 despite negative test my dr began antibiotic therapy for lyme.Within 4 months, i experienced a marked shift two years of antibiotic therapy along with physical therapy and nutritional therapy followed.I am permanently disabled for the rest of my life.A valid competent test would have resulted in prompt treatment and prevented years of misery.Would have prevented permanent damage and disability.I do not readily have the dates of my tests as i was a traveller rn at the time.My tests were ordered by different drs in several states.I will research and provide the info upon request.My life has been severely impacted to a degree i struggle to express.Fda safety report id# (b)(4).

• Brand Name: LYME TESTING
• Type of Device: REAGENT, BORRELIA SEROLOGICAL REAGENT
• MDR Report Key: 8675452
• MDR Text Key: 147439657
• Report Number: MW5087178
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR