MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-12 for BIOSITE TRIAGE DRUGS OF ABUSE KIT * manufactured by *.
[539431]
During ed visit urine for drug screen received and tested. Pt c/o that the drug screen positive results were "in error" eleven days later. Pt's specimen retreived and retested. All results negative. Mfr notified, facility received technical bulletin and information detailing possible false positive reactions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040410 |
| MDR Report Key | 759957 |
| Date Received | 2006-09-12 |
| Date of Report | 2006-09-05 |
| Date of Event | 2006-08-11 |
| Date Added to Maude | 2006-09-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 DRUGS OF ABUSE KIT |
| Generic Name | URINE TEST KIT |
| Product Code | MGX |
| Date Received | 2006-09-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 163238 |
| ID Number | NA |
| Device Expiration Date | 2007-12-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 747876 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-12 |