FDA Adverse Event
Malfunction
Summary report: N
TELCARE BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 4425642
·
Received January 8, 2015
Report
- Report Number
- 3008514395-2014-00003
- Event Type
- Malfunction
- Date Received
- January 8, 2015
- Manufacturer
- TELCARE INC.
- Product Code
- NBW
- PMA / PMN Number
- K110571
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
(B)(4)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20030 | TELCARE BLOOD GLUCOSE MONITORING SYSTEM | TELCARE BGM | NBW | TELCARE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |