MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for CARDIOCHEK PLUS ANALYZER 5700411 manufactured by Pts Diagnostics.
| Report Number | 1836135-2020-00009 |
| MDR Report Key | 9699197 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRANDON UNRUH |
| Manufacturer Street | 7736 ZIONSVILLE ROAD |
| Manufacturer City | INDIANAPOLIS, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 8705610 |
| Manufacturer G1 | PTS DIAGNOSTICS |
| Manufacturer Street | 7736 ZIONSVILLE ROAD |
| Manufacturer City | INDIANAPOLIS, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCHEK PLUS ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CGA |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-03 |
| Model Number | 5700411 |
| Catalog Number | 5700411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PTS DIAGNOSTICS |
| Manufacturer Address | 7736 ZIONSVILLE ROAD INDIANAPOLIS, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |