MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-05 for PINK OR BLUE EARLY DNA GENDER TEST manufactured by Consumer Genetics.
[21641796]
Consumer genetics pink or blue gender test produced incorrect result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020932 |
| MDR Report Key | 2119950 |
| Date Received | 2011-06-05 |
| Date of Report | 2011-06-05 |
| Date of Event | 2011-02-10 |
| Date Added to Maude | 2011-06-17 |
| 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 |
| 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 | PINK OR BLUE EARLY DNA GENDER TEST |
| Generic Name | PINK OR BLUE EARLY DNA GENDER TEST |
| Product Code | LHD |
| Date Received | 2011-06-05 |
| Lot Number | KIT ID: 13692 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSUMER GENETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-05 |