FDA Adverse Event
Malfunction
Summary report: N
OT PING ENHANCED METER
MDR report key: 2493015
·
Received March 15, 2012
Report
- Report Number
- 2939301-2012-02565
- Event Type
- Malfunction
- Date Received
- March 15, 2012
- Date of Event
- February 23, 2012
- Report Date
- February 23, 2012
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS EXPECTED TO BE RETURNED.PRODUCT CODE FOR THIS DEVICE IS NBW.
Description of Event or Problem · 1
THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE UNIT POWERS OFF DURING USE WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING ENHANCED METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3227279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |