FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 3111371
·
Received May 14, 2013
Report
- Report Number
- 3008382007-2013-05411
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Report Date
- February 20, 2013
- Manufacturer
- LIFESCAN EUROPE GMBH
- Product Code
- NBW
- PMA / PMN Number
- K110637
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214002 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Unknown |