MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for ALINIQ AMS 03R89-21 manufactured by Abbott S.r.l..
| Report Number | 3004032053-2020-00002 |
| MDR Report Key | 9812613 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-10 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT S.R.L. |
| Manufacturer Street | PIAZZA DELLA TRIVULZIANA, 4/A |
| Manufacturer City | MILAN 20126 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINIQ AMS |
| Generic Name | ANALYZER MANAGEMENT SYSTEM |
| Product Code | JQP |
| Date Received | 2020-03-10 |
| Model Number | 03R89-21 |
| Catalog Number | 03R89-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT S.R.L. |
| Manufacturer Address | PIAZZA DELLA TRIVULZIANA, 4/A MILAN 20126 IT 20126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |