WESTERN BLOT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-06 for WESTERN BLOT manufactured by .

Event Text Entries

[5305240] I became very ill ever a long period of time, little by little. The drs treated me with elisa and western blot for lyme disease, it was negative. I was tested 3 more time, they were negative. I continued to get sicker and sicker. Some of my problems are brain lesions, inappropriate sinus tachycardia, neurocardiogenic syncope, costochondritis, ulcerative colitis, interstitial cystitis, frequent infectious cystitis, dry eyes, muscle spasms, arthritis, epilepsy, and so on. Unfortunately, i was misdiagnosed with ms due to the brain lesions and neg. Lyme tests. After more than a decade i took a list of symptoms to my primary care doctor and i had 38 out of 70, so i got the diagnosis. I went on to see a lyme disease specialist and she asked if i had any rashes. Yes, i had a circular rash with a clear center that grew bigger and bigger for a week. It was the lyme disease bull's eye. She was the only doctor that ever asked. The lyme bull's eye in and of itself, can diagnose lyme disease. So, i have multiple symptoms and a bull's eye, but the elisa and western blots said negative = false negative. Now, i have to see multiple specialists (who all believe i have chronic lyme), i am told i will never be cured, the damage is done. My story isn't uncommon. As a matter of fact, it was through someone else's experience i found the ms was a misdiagnosis and i actually had lyme disease. It's time to develop better testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040150
• MDR Report Key: 4408289
• Date Received: 2015-01-06
• Date of Report: 2015-01-06
• Date of Event: 2006-09-30
• Date Added to Maude: 2015-01-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: WESTERN BLOT
• Generic Name: WESTERN BLOT FOR LYME DISEASE
• Product Code: LSR
• Date Received: 2015-01-06
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: ELISA
• Generic Name: ELISA FOR LYME DISEASE
• Product Code: MJH
• Date Received: 2015-01-06
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Deathisabilit	2015-01-06