MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2003-09-30 for STAT PROFILE M MGH SENSOR I MAGNESIUM ELECTRODE 20394 manufactured by Nova Biomedical Corp..
[295031]
Customer reported low mg++ results on pts' samples, below reference range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2003-00003 |
| MDR Report Key | 486709 |
| Report Source | 01,05 |
| Date Received | 2003-09-30 |
| Date of Report | 2003-09-29 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-08-01 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2003-10-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL MAC DONALD |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 02454 |
| Manufacturer Country | US |
| Manufacturer Postal | 02454 |
| Manufacturer Phone | 7818940800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT PROFILE M MGH SENSOR |
| Generic Name | IONIZED MAGNESIUM SENSOR |
| Product Code | CFA |
| Date Received | 2003-09-30 |
| Model Number | I MAGNESIUM ELECTRODE |
| Catalog Number | 20394 |
| Lot Number | 212043 |
| ID Number | * |
| Device Expiration Date | 2003-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 475595 |
| Manufacturer | NOVA BIOMEDICAL CORP. |
| Manufacturer Address | 200 PROSPECT ST. WALTHAM MA 02454 US |
| Baseline Brand Name | STAT PROFILE M MGH SENSOR |
| Baseline Generic Name | IONIZED MAGNESIUM SENSOR |
| Baseline Model No | I MAGNESIUM ELE |
| Baseline Catalog No | 20394 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-30 |