MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-10 for ATTELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) 10995523 manufactured by Siemens Healthcare Diagnostics, Inc..
| Report Number | 1219913-2019-00204 |
| MDR Report Key | 9176997 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-10 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2019-02-06 |
| Date Added to Maude | 2019-10-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. STACY LOUKOS |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086608576 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) |
| Generic Name | CEA IMMUNOASSAY |
| Product Code | DHX |
| Date Received | 2019-10-10 |
| Catalog Number | 10995523 |
| Lot Number | 47916186 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-10 |