N
Patient 1
INVESTIGATION PENDING.
MAUDE MDR 6862631
- MDR report key
- 6862631
- Report number
- 2027969-2017-00144
- Event key
- 0
- Event type
- 3
- Date received
- 2017-09-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YA-LING KING
- Address
- 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US
- Phone
- 858-858-8588
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ALERE ISCREEN 6 PANEL TEST | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES | ALERE SAN DIEGO, INC. | DIO | DOA-264 | DOA6110466 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-13 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE BZO AND COC RESULTS USING THE ALERE ISCREEN 6 PANEL TEST. LABORATORY TESTING PRODUCED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.