MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for TRIAGE CARDIAC TNI PANEL 97021HS manufactured by Quidel Cardiovascular Inc..
| Report Number | 3013982035-2020-00009 |
| MDR Report Key | 9875578 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-10-14 |
| Date Added to Maude | 2020-03-24 |
| 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 | JESSICA PERROTTE |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3020297 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE CARDIAC TNI PANEL |
| Generic Name | TRIAGE CARDIAC TNI PANEL |
| Product Code | MMI |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 97021HS |
| Catalog Number | 97021HS |
| Lot Number | T11000RN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CARDIOVASCULAR INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |