FDA Adverse Event
Malfunction
Summary report: N
TRIAGE
MDR report key: 1970462
·
Received January 18, 2011
Report
- Report Number
- 2027969-2011-00124
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 28, 2010
- Report Date
- January 18, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- NBC
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT THIS METER IS NOT OPERATIONAL AND THAT THERE SEEMS TO BE A BURNING SMELL COMING FROM THE METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE | CARDIAC MARKER TEST | NBC | ALERE SAN DIEGO, INC. | 55070 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |