MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for NOVA STAT PROFILE CRITICAL CARE XPRESS 35942 manufactured by Nova Biomedical Corporation.
[114677454]
Patient's procedure was delayed for hydration therapy based on the creatinine result of 1. 7. Nova biomedical opened an internal investigation into the incident.
Patient Sequence No: 1, Text Type: N, H10
[114677455]
Pt scheduled for r&l heart cath poc creatinine ran in unit and resulted at 1. 7, procedure delayed for hydration therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2018-00001 |
| MDR Report Key | 7694958 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-07-17 |
| 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 02453 |
| Manufacturer Country | US |
| Manufacturer Postal | 02453 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORP. |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 02453 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02453 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOVA STAT PROFILE CRITICAL CARE XPRESS |
| Generic Name | CLINICAL CHEMISTRY CREATININE TEST SYSTEM |
| Product Code | CGL |
| Date Received | 2018-07-17 |
| Model Number | 35942 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 024533465 US 024533465 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-17 |