FDA Adverse Event
Death
Summary report: N
TOX/SEE DRUG SCREEN
MDR report key: 3601909
·
Received January 17, 2014
Report
- Report Number
- 2915274-2014-00001
- Event Type
- Death
- Date Received
- January 17, 2014
- Report Date
- January 21, 2014
- Manufacturer
- BIO-RAD LABORATORIES INC
- Product Code
- DIO
- PMA / PMN Number
- K031759
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2014, A CUSTOMER REPORTED DISCREPANT RESULTS USING TOX/SEE KIT 195-5221. THE RESULTS SHOWED POSITIVE FOR BENZODIAZEPINES (BZO), TRICYCLIC ANTIDEPRESSANTS (TCA), OPIATES, METHAMPHETAMINES, AND THC. F/U TESTING SHOWED POSITIVE FOR BZO, TCA, AND THC, BUT NEGATIVE FOR OPIATES AND METHAMPHETAMINES. THE PT REPORTEDLY DIED OF AN OVERDOSE. DUE TO THE LIMITED INFO PROVIDED IT IS UNCLEAR IF THE TOX/SEE DRUG SCREEN MALFUNCTIONED OR LED TO THIS ADVERSE EVENT REPORT. INVESTIGATION IS ONGOING AND ADD'L PRODUCT INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45549 | TOX/SEE DRUG SCREEN | TOX/SEE | DIO | BIO-RAD LABORATORIES INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Death | UNK IF PHYSICIAN UTILIZED ADD'L MEDICAL PRODUCTS| OR THERAPIES PRIOR TO OR AFTER TREATMENT OF EVENT |