MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-24 for AT HOME DRUG TEST PHARATECH * manufactured by Phamatech.
[15687806]
Complainant owns a construction business and routinely tests their employees for use of the drug marijauna. For the last 8 weeks they have been using the referenced over-the-counter in vitro diagnostic test kits on their employees and they have consistently tested positive (weekly tests) they became suspicious because they were certain that not all them smoked marijuana. So they tested themselves 4 or 5 times over the last month and they tested positive every time including two days ago. They claim they have not used marijuana. So they are claiming that the test is very defective in that it is giving many false positives. Labeling claims that is 99% effective and "fda cleared" they stated that (obviously) false positives causes alot of problems for users in the form of lost jobs, incorrect drug use info on records, etc. There is an approved 510k for this test kit and many others (510k number k994220).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003602 |
| MDR Report Key | 490478 |
| Date Received | 2003-09-24 |
| Date of Report | 2003-07-31 |
| Date Added to Maude | 2003-10-23 |
| 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 | AT HOME DRUG TEST PHARATECH |
| Generic Name | SINGLE PANEL TEST FOR MARIJUANA THC |
| Product Code | MVO |
| Date Received | 2003-09-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 479209 |
| Manufacturer | PHAMATECH |
| Manufacturer Address | 9530 PADGETT STREET #101-106 SAN DIEGO CA 92126 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-24 |