MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-23 for BIOSITE TRIAGE FOX DRUG SCREEN TEST DEIVCE * 1394000 manufactured by Biosite Triage.
[496239]
Testing device suspected of false/positive results when one pt's results showed barbituate and amphetamine use and pt denied use. 2nd test proved no drug use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036415 |
| MDR Report Key | 752105 |
| Date Received | 2005-08-23 |
| Date Added to Maude | 2006-08-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSITE TRIAGE FOX DRUG SCREEN TEST DEIVCE |
| Generic Name | TEST KIT (URINE) |
| Product Code | MGX |
| Date Received | 2005-08-23 |
| Model Number | * |
| Catalog Number | 1394000 |
| Lot Number | W35526 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 739889 |
| Manufacturer | BIOSITE TRIAGE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-23 |