MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-06 for ECRE_2 REAGENTS (4 X 350 TESTS) - ENZ ADVIA CHEMISTRY XPT - ECRE_2 10335869 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2432235-2020-00227 |
| MDR Report Key | 9802039 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-06 |
| 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 | MR. MARDOCHEE TIMOLIEN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 5242503 |
| Manufacturer G1 | SEKISUI DIAGNOSTICS PEI INC. |
| Manufacturer Street | 70 WATTS AVENUE REGISTRATION # 8020316 |
| Manufacturer City | CHARLOTTETOWN, PE C1E 2B9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | C1E 2B9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECRE_2 REAGENTS (4 X 350 TESTS) - ENZ |
| Generic Name | ADVIA CHEMISTRY XPT - ECRE_2 |
| Product Code | JFY |
| Date Received | 2020-03-06 |
| Model Number | ADVIA CHEMISTRY XPT - ECRE_2 |
| Catalog Number | 10335869 |
| Lot Number | 54373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |