MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-13 for VERIFI DAN TEST manufactured by .
[18543850]
We had received a positive result for turner syndrome from the verifi blood test. Our amnio results came back as 100% normal cells. Me and my husband went through hell for 4 weeks. Nipt tests (verifi, maternity21, panorama) should reconsider their "accuracy" 99% for sex hormones, because they give a lot of false positive results as can be seen here: (b)(6). Mfr reported as progenity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041521 |
| MDR Report Key | 4617054 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-13 |
| Date Added to Maude | 2015-03-20 |
| 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 | 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 | VERIFI DAN TEST |
| Generic Name | VERIFI DAN TEST |
| Product Code | PFF |
| Date Received | 2015-03-13 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-13 |