MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for CARDIOCHEK PLUS ANALYZER manufactured by Pts Diagnostics.
| Report Number | 1836135-2019-00056 |
| MDR Report Key | 9103994 |
| Date Received | 2019-09-23 |
| Date of Report | 2019-09-23 |
| Date Mfgr Received | 2019-09-06 |
| Date Added to Maude | 2019-09-23 |
| 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 |
| 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 46278 |
| Manufacturer Country | US |
| Manufacturer Postal | 46278 |
| Manufacturer Phone | 3178705610 |
| Manufacturer G1 | PTS DIAGNOSTICS |
| Manufacturer Street | 7736 ZIONSVILLE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46278 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46278 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARDIOCHEK PLUS ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CGA |
| Date Received | 2019-09-23 |
| Returned To Mfg | 2019-09-11 |
| 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 46278 US 46278 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-23 |