MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-07 for TRIAGE * manufactured by Biosite Incorporated.
[1645384]
Test done on patient using the product. The test result was reported as positive, >50 for tetrahydrocannabinol(thc). Patient contacted risk management to report she has never used this drug and was concerned about the results. Later during investigation a letter from manufacturer of test revealed it has had many occurrences of false positive with this test. ====================== health professional's impression======================biosite, the manufacturer of product sent out a product advisory notice that states there was an increase in the number of customer calls re unexpected positive thc results when using this test. ====================== manufacturer response for drug screening test, triage tox drug screen pn 94400======================received notice from company at same time we were investigating this patient's complaint about the unexpected number positive results of this test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1653884 |
| MDR Report Key | 1653884 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-04-07 |
| Date of Event | 2010-02-27 |
| Report Date | 2010-04-07 |
| Date Reported to FDA | 2010-04-07 |
| Date Added to Maude | 2010-04-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE |
| Generic Name | DRUG SCREENING TEST |
| Product Code | MGX |
| Date Received | 2010-04-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-07 |