MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-15 for TRIAGE CARDIAC PANEL * manufactured by Biosite, Inc..
[335800]
During method correlation between biosite triage cardiac panel against dade rxl myoglobin, user encountered a "hook effect" resulting in decreased values on the biosite method.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031527 |
| MDR Report Key | 517493 |
| Date Received | 2004-03-15 |
| Date of Report | 2004-03-15 |
| Date Added to Maude | 2004-03-26 |
| 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 | 3 |
| 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 | LABORATORY DIAGNOSTIC |
| Product Code | JHY |
| Date Received | 2004-03-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 32543 |
| ID Number | * |
| Device Expiration Date | 2004-08-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 506530 |
| Manufacturer | BIOSITE, INC. |
| Manufacturer Address | 11030 ROSELLE ST SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-15 |