FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 1904823
·
Received November 22, 2010
Report
- Report Number
- 2939301-2010-10151
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Report Date
- November 8, 2010
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K082590.
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 LINE THROUGH DISPLAY WAS NOT RESOLVED WITH TROUBLESHOOTING.
Description of Event or Problem · 1
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3043953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |