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MAUDE Adverse Event Report: ELISA ; LYME TEST
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TPLC
ELISA ; LYME TEST
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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.
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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
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Was Device Available for Evaluation?
No
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
01/18/2017
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
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