MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-02 for TRIAGE - DRUGS OF ABUSE PANEL PLUS TCA * 92000 manufactured by Biosite Diagnostics.
[128068]
Drug screen testing done on pt reported as positive for cocaine and amphetamines. Family questioned results and specimen was sent to outside lab which reported no drugs found. Specimen retested here with same positive results. Same specimen sent to second outside lab which reported no drugs found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016051 |
| MDR Report Key | 217343 |
| Date Received | 1999-04-02 |
| Date of Report | 1999-03-31 |
| Date of Event | 1999-02-16 |
| Date Added to Maude | 1999-04-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 - DRUGS OF ABUSE PANEL PLUS TCA |
| Generic Name | LAB TEST |
| Product Code | MGX |
| Date Received | 1999-04-02 |
| Model Number | * |
| Catalog Number | 92000 |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 1999-09-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 210809 |
| Manufacturer | BIOSITE DIAGNOSTICS |
| Manufacturer Address | 11030 ROSELLE STREET SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-02 |