MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM 43370 manufactured by Nova Biomedical Corporation.
[130052902]
No adverse event reported, investigation ongoing.
Patient Sequence No: 1, Text Type: N, H10
[130052903]
Discrepant creatinine results using nova stat sensor compared to lab reference. Patient received wrong contrast as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2018-00009 |
| MDR Report Key | 8151907 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-11 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2018-12-11 |
| 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 | MS. TAYLOR WARD |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 024543465 |
| Manufacturer Country | US |
| Manufacturer Postal | 024543465 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORPORATION |
| Manufacturer Street | 200 PROSPECT STREET |
| Manufacturer City | WALTHAM MA 024543465 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 024543465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM |
| Generic Name | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| Product Code | CGL |
| Date Received | 2018-12-11 |
| Model Number | 43370 |
| Lot Number | 4918192129 |
| Device Expiration Date | 2019-07-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORPORATION |
| Manufacturer Address | 200 PROSPECT STREET WALTHAM MA 024543465 US 024543465 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |