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 |