MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-26 for TRIAGE DRUGS OF ABUSE PANEL WITH TCA 92000 manufactured by Biosite.
[17446794]
Since (b)(6) 2013, across at least 3 lot numbers of product, we have been intermittently getting false positive barbiturate results using the triage drugs of abuse panel with tca.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029995 |
| MDR Report Key | 3088865 |
| Date Received | 2013-04-26 |
| Date of Report | 2013-04-26 |
| Date Added to Maude | 2013-05-03 |
| 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 | DRUGS OF ABUSE PANEL |
| Product Code | MGX |
| Date Received | 2013-04-26 |
| Catalog Number | 92000 |
| Lot Number | 300486 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE |
| Manufacturer Address | SAN DIEGO CA US |
| Brand Name | TRIAGE DRUGS OF ABUSE PANEL WITH TCA |
| Generic Name | DRUGS OF ABUSE PANEL |
| Product Code | MGX |
| Date Received | 2013-04-26 |
| Catalog Number | 92000 |
| Lot Number | 300487 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE |
| Manufacturer Address | SAN DIEGO CA US |
| Brand Name | TRIAGE DRUGS OF ABUSE PANEL WITH TCA |
| Generic Name | DRUGS OF ABUSE PANEL |
| Product Code | MGX |
| Date Received | 2013-04-26 |
| Catalog Number | 92000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-26 |