MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-25 for TRIAGE DRUGS OF ABUSE PANEL 95000 manufactured by Biosite Diagnositcs.
[8120]
Pt's urine specimen was tested on 2/10/94 using the device method. The drugs of abuse screen yielded negative results for all parameters. The test was repeated at the request of the er physician, and the results were the same. All parameters were negative. The er physician did not believe the results because a friend of the pt expressed witnessing the pt's use of cocaine. The urine specimen was sent to another lab for a cocaine screen using another co's method. The specimen tested positive for cocaine. Serum was sent for cocaine/metabolite quantitation. The result was 4159 ng/ml as benzoylecgnonine. Device demonstrated false negative results. Product taken out of service at hosp 2/10/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000892 |
| MDR Report Key | 11749 |
| Date Received | 1994-02-25 |
| Date of Report | 1994-02-21 |
| Date of Event | 1994-02-10 |
| Date Added to Maude | 1994-02-28 |
| 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 | TRIAGE DRUGS OF ABUSE PANEL |
| Product Code | MGX |
| Date Received | 1994-02-25 |
| Catalog Number | 95000 |
| Lot Number | W4127 |
| Device Expiration Date | 1994-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11749 |
| Manufacturer | BIOSITE DIAGNOSITCS |
| Manufacturer Address | SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-25 |