MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-29 for HERPESELECT ELISA manufactured by .
[4070508]
I requested an std panel from (b)(4), who used (b)(4) to perform the (b)(6) test. I unexpectedly received a positive result for (b)(6), despite being zero-risk and totally asymptomatic. On researching extensively, i discovered that this test has a false rate of 50% for results less than 3. 5. (my result was (b)(6), with normal being (b)(6). ) this test should not be on the market. Reason for use: to rule out (b)(6), something this test does not do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034113 |
| MDR Report Key | 3603233 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-28 |
| Date of Event | 2013-11-29 |
| Date Added to Maude | 2014-02-04 |
| 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 |
| Brand Name | HERPESELECT ELISA |
| Generic Name | NONE |
| Product Code | LGC |
| Date Received | 2014-01-29 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-29 |