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 2020-03-26 for ATELLICA IM 1300 ANALYZER 11066001 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2432235-2020-00251 |
| MDR Report Key | 9884116 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-02-29 |
| Date Added to Maude | 2020-03-26 |
| 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 | ROLANDO HUALPA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 5242963 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD REGISTRATION #: 2247117 |
| Manufacturer City | FLANDERS, NJ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATELLICA IM 1300 ANALYZER |
| Generic Name | ATELLICA IM 1300 ANALYZER |
| Product Code | JJE |
| Date Received | 2020-03-26 |
| Model Number | ATELLICA IM 1300 |
| Catalog Number | 11066001 |
| 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 | 2020-03-26 |