MAUDE Adverse Event Report: ELISA ; LYME TEST

Device Problem False Negative Result (1225)

Patient Problems Bacterial Infection (1735); Misdiagnosis (2159)

Event Date 07/28/2013

Event Type  Injury  

Event Description

Because the tier i and tier ii lyme tests were never approved for nor meant to be a diagnostic tool, i was misdiagnosed for many years.I now have late stage lyme disease which is incurable.

• Brand Name: ELISA
• Type of Device: LYME TEST
• MDR Report Key: 6267447
• MDR Text Key: 65501291
• Report Number: MW5067365
• 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: 01/18/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS, OTC MEDS: TOO MANY TO LIST
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 75