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 2020-02-19 for ARCHITECT STAT HIGH SENSITIVE TROPONIN-I 03P25-37 manufactured by Abbott Ireland Diagnostics Division Longford.
| Report Number | 3005094123-2020-00043 |
| MDR Report Key | 9729453 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2020-02-02 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-02-19 |
| 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 IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT STAT HIGH SENSITIVE TROPONIN-I |
| Generic Name | TROPONIN-I |
| Product Code | MMI |
| Date Received | 2020-02-19 |
| Catalog Number | 03P25-37 |
| Lot Number | 08408UI00 |
| Device Expiration Date | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |