MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-03 for ALERE TRIAGE TOX DRUG SCREEN PN 94400 manufactured by Alere.
[15779284]
False negative results on the tricyclic drug screen. Alere triage tox ds lot number 50995. Thc - gave false positive results on (b)(6) 2012, with alere triage tox drug screen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026419 |
| MDR Report Key | 2688507 |
| Date Received | 2012-08-03 |
| Date of Report | 2012-08-03 |
| Date of Event | 2012-06-16 |
| Date Added to Maude | 2012-08-13 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE TRIAGE TOX DRUG SCREEN PN 94400 |
| Generic Name | ALERE TRIAGE TOX DRUG SCREEN PN 94400 |
| Product Code | DIF |
| Date Received | 2012-08-03 |
| Catalog Number | PN 94400 |
| Lot Number | 50995 |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE |
| Manufacturer Address | 9975 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2012-08-03 |