MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for TOXICOLOGY SCREEN AU 680 ISE manufactured by Beckman Coulter.
[53442708]
Urine drug screen (uds) drawn (b)(6) 2016 for toxicology test and was reported with negative results. Urine drug screen repeated (b)(6) 2016 at 1800 with different results of positive for amp/methamp, benzodiazepines, cannabinoids, opiates. Repeat testing of the first specimen showed positive results. Unresponsive patient had a lumbar puncture performed because patient condition could not be explained when the drug screen came back negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064342 |
| MDR Report Key | 5905423 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-07-09 |
| Date Added to Maude | 2016-08-26 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOXICOLOGY SCREEN |
| Generic Name | TOXICOLOGY SCREEN |
| Product Code | DIF |
| Date Received | 2016-08-23 |
| Model Number | AU 680 ISE |
| ID Number | 7801626 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-23 |