MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for WESTERN BLOT manufactured by Unk.
[89952918]
I was tested for lyme disease 6 times by the 2 tier testing method that showed negative results. After suffering for 2 years, i finally got a positive result from a specialty lab that confirmed i had lyme. Due to poor testing methods, i am now disabled. Effective treatment at the very beginning of my illness would have saved me the expense and suffering i had to endure. Please remove the 2 tier testing protocol so other people will not have to go through what i did. Thank you. Tests need to be perfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072860 |
| MDR Report Key | 6964625 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-18 |
| Date of Event | 2008-05-20 |
| Date Added to Maude | 2017-10-20 |
| 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 | HOME HEALTH AIDE |
| 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 | WESTERN BLOT |
| Generic Name | WESTERN BLOT |
| Product Code | LSR |
| Date Received | 2017-10-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | ELISA |
| Generic Name | ELISA |
| Product Code | LSR |
| Date Received | 2017-10-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2017-10-20 |