MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for ELISA TEST SYSTEM manufactured by .
[32672045]
I took the lyme elisa test in (b)(6) 2012 and the test came back negative. Because of this, i stopped even considering lyme disease and started searching other paths. I finally took a western blot test for lyme disease in (b)(6) 2013 and was cdc positive. The delay in getting my diagnosis exacerbated my symptoms and made me miss many months of work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058271 |
| MDR Report Key | 5264050 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-30 |
| Date of Event | 2013-01-08 |
| Date Added to Maude | 2015-12-03 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELISA TEST SYSTEM |
| Generic Name | ELISA TEST SYSTEM |
| Product Code | LSR |
| Date Received | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Deathisabilit | 2015-11-30 |