MAUDE Adverse Event Report: ELISA FOR LYME

Device Problems False Negative Result (1225); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fatigue (1849); Rash (2033); Joint Swelling (2356); Disability (2371)

Event Date 12/16/2004

Event Type  Injury  

Event Description

I developed a swollen left knee overnight (b)(6) 2004, no injury, had strange rash on multiple areas of body and increasing fatigue.I was unable to get referral to ortho (in an (b)(4)) till (b)(4) 2004.He used lyme elisa which was negative so he was told me i did not have lyme, even though i got sicker and sicker over the years until i was bedridden in 2008.Lyme was never thought of again.Finally after seeing multiple providers, my husband took me to an integrative family practice md, in the (b)(6) where they are very familiar with lyme.I already had been tested for all autoimmune diseases and was tested negative.He did further immune and endocrine testing and a lyme wb, it was indeterminate by (b)(4) standards, but positive for 31 and 34 bands.Since i had never had the lymerix vaccine, there was no way to be positive unless i had been exposed to the spirochete.I began treatment and then tested again by elisa and wb, elisa remained negative but now was positive by (b)(4) state standards.It took years of supportive treatment to regain enough function to have a life, but i am now disable; i was an rn but had to quit in 2008 when i could physically no longer do the job.Due to the use of only the elisa and disregarded for obvious physical symptoms, my life was changed forever.Manufacturer name: labcorp.

• Brand Name: ELISA FOR LYME
• Type of Device: ELISA
• MDR Report Key: 4060121
• MDR Text Key: 4730443
• Report Number: MW5038047
• 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: Patient
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 52 YR
• Patient Weight: 64