MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-09 for TRIAGE DRUGS OF ABUSE PANEL WITH TCA 92000 manufactured by Alere.
[3570343]
Pt's drug screen was reported as positive. Pt denied use of drugs. Sample was sent to reference lab for confirmation and found to be negative. This is the second occurrence of false positives that our institution has revealed using the alere triage drugs of abuse panel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030856 |
| MDR Report Key | 3226613 |
| Date Received | 2013-07-09 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-06-25 |
| Date Added to Maude | 2013-07-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TRIAGE DRUGS OF ABUSE PANEL WITH TCA |
| Generic Name | TRIAGE DRUGS OF ABUSE PANEL WITH TCA |
| Product Code | MGX |
| Date Received | 2013-07-09 |
| Model Number | 92000 |
| Lot Number | 300488 |
| Device Expiration Date | 2014-12-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-09 |