MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-20 for TRIAGE 95000 manufactured by Biosite Diagnostic.
[7709]
Drug screen on a urine specimen yielded a false negative result. The device used with expiration date of 9/30/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000135 |
| MDR Report Key | 10558 |
| Date Received | 1993-12-20 |
| Date of Report | 1993-12-15 |
| Date of Event | 1993-11-30 |
| Date Added to Maude | 1993-12-21 |
| 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 |
| 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 |
| Generic Name | DRUG SCREEN REAGENT SYSTEM |
| Product Code | DIS |
| Date Received | 1993-12-20 |
| Catalog Number | 95000 |
| Lot Number | W3834 |
| Device Expiration Date | 1993-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10558 |
| Manufacturer | BIOSITE DIAGNOSTIC |
| Manufacturer Address | SAN DIEGO CA 921211208 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-12-20 |