FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2810407
·
Received October 31, 2012
Report
- Report Number
- 2939301-2012-12534
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Report Date
- October 17, 2012
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- PMA / PMN Number
- K082590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP #1 (SUBMISSION 12/04/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE METER WITH THE COMPLAINT ON (B)(4) 2012 AND COMPLETED DEVICE EVALUATION ON (B)(4) 2012. INVESTIGATION WAS NOT ABLE TO CONFIRM THE ALLEGED COMPLAINT: THE METER PASSED TESTING WITH NO FAULTS FOUND.
Additional Manufacturer Narrative · 1
NO PRODUCT IS EXPECTED TO BE RETURNED.
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 UP ARROW BUTTON WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3217900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |