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 2020-03-27 for ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER 10316162 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2432235-2020-00256 |
| MDR Report Key | 9891576 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2004-10-04 |
| Date Added to Maude | 2020-03-27 |
| 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 | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 5242740 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE, SWORDS, CO. |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER |
| Generic Name | ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER |
| Product Code | GKZ |
| Date Received | 2020-03-27 |
| Model Number | ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE |
| Catalog Number | 10316162 |
| 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 AVE TARRYTOWN, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |