MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2 53657 manufactured by Nova Biomedical Corporation.
[78029773]
A review of the customer complaint information confirmed that the patient was not mistreated due to the identified software issue. Nova has also confirmed that this is the first complaint that we have received due to this reported software issue. Decision to initiate a field correction to immediately correct the software issue associated with the use of stat profile prime auto-cartridge quality control (a-qc) materials. The investigation is currently in process.
Patient Sequence No: 1, Text Type: N, H10
[78029774]
Prime analyzer s/n (b)(4) failing to flag a patient critical ph level.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2017-00006 |
| MDR Report Key | 6651879 |
| Date Received | 2017-06-19 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2015-11-24 |
| Date Added to Maude | 2017-06-19 |
| 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 | MRS. RACHEL KULA |
| Manufacturer Street | 200 PROSPECT STREET |
| Manufacturer City | WALTHAM MA 02453 |
| Manufacturer Country | US |
| Manufacturer Postal | 02453 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORPORATION |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 024533465 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 024533465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2 |
| Generic Name | ANALYZER |
| Product Code | GKF |
| Date Received | 2017-06-19 |
| Model Number | 53657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORPORATION |
| Manufacturer Address | 200 PROSPECT ST WALTHAM MA 02454 US 02454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-19 |