FDA Adverse Event
Malfunction
Summary report: N
ONE STEP COCAINE TEST STRIP
MDR report key: 3928493
·
Received June 6, 2014
Report
- Report Number
- 2027969-2014-00550
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 13, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- DKZ
- PMA / PMN Number
- K010841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGING RECEIVING DISCREPANT CORRELATION ISSUE. POSITIVE COC ON SINGLE DRUG TEST VS NEGATIVE COC ON ICUP (I-DUA-157-013). SINGLE PANEL ISCREEN COC SHOWED POSITIVE. ICUP MULTIDRUG TEST SHOWED NEGATIVE FOR COC. URINE IS FRESH, 90-100 DEGREES. NO CONFIRMATORY LAB RESULTS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332270 | ONE STEP COCAINE TEST STRIP | DRUGS OF ABUSE | DKZ | ALERE SAN DIEGO, INC. | DCO-101 | COC3050023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNSPECIFIED LATERAL FLOW DRUG SCREEN |