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 |