MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-27 for MULTI-DRUG SCREEN TEST PANEL manufactured by Innovacon, Inc..
[17472875]
I do on-site drug testing at a mfg facility in (b)(6). I am currently using "multi-drug screen test panel" distributed by (b)(4). Lot number doa0030282, exp date 01/2012; catalog number doa-354. I have had numerous tests that failed to completely develop. The result has been that i have had to repeat the test using another test cassette. I consider this a product failure. Diagnosis or reason for use: on site drug testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018741 |
| MDR Report Key | 1944099 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-27 |
| Date of Event | 2010-12-20 |
| Date Added to Maude | 2011-01-21 |
| 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 | 3 |
| 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 | MULTI-DRUG SCREEN TEST PANEL |
| Generic Name | ON SITE DRUG SCREEN, COC/AMP/THC/OPI/PCP |
| Product Code | DKZ |
| Date Received | 2010-12-27 |
| Lot Number | DOA0030282 |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-27 |