MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) 20-006-021 20-005-021 manufactured by Nanosphere, Inc..
| Report Number | 3006028115-2019-00001 |
| MDR Report Key | 8809480 |
| Date Received | 2019-07-19 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-06-10 |
| Date Mfgr Received | 2019-06-20 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2019-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG MASCHEK |
| Manufacturer Street | 12212 TECHNOLOGY BLVD |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5122195195 |
| Manufacturer G1 | NANOSPHERE, INC. |
| Manufacturer Street | 4088 COMMERCIAL AVENUE |
| Manufacturer City | NORTHBROOK IL 60062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) |
| Generic Name | GRAM-NEGATIVE BLOOD CULTURE TEST |
| Product Code | PEN |
| Date Received | 2019-07-19 |
| Model Number | 20-006-021 |
| Catalog Number | 20-005-021 |
| Lot Number | 031519021B |
| Device Expiration Date | 2019-09-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NANOSPHERE, INC. |
| Manufacturer Address | 4088 COMMERCIAL AVENUE NORTHBROOK IL 60062 US 60062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-19 |