MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-21 for TRIAGE CARDIAC PANEL * 9700 manufactured by Biosite Diagnostics.
[211464]
Six total pt cartridges of biosite triage cardiac panel tested 0. 0 for myoglobin. These came from the same box. Nine other boxes of the same lot number received on the same shipment had been tested. Of the 325 tests no other false zeros were obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023458 |
| MDR Report Key | 362119 |
| Date Received | 2001-11-21 |
| Date of Report | 2001-11-21 |
| Date of Event | 2001-11-11 |
| Date Added to Maude | 2001-11-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE CARDIAC PANEL |
| Generic Name | FLUORESCENCE IMMUNOASSAY |
| Product Code | MVE |
| Date Received | 2001-11-21 |
| Returned To Mfg | 2001-11-14 |
| Model Number | * |
| Catalog Number | 9700 |
| Lot Number | W24165B |
| ID Number | 80053 |
| Device Expiration Date | 2001-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 351273 |
| Manufacturer | BIOSITE DIAGNOSTICS |
| Manufacturer Address | 11030 ROSELLE ST SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-21 |