FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2003345
·
Received March 1, 2011
Report
- Report Number
- 2939301-2011-01675
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Report Date
- February 18, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
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 THE METER HAS UNKNOWN ERROR MESSAGE ON THE DISPLAY AND DISPLAYS ERROR 2. THESE ISSUES WERE 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. | 3042844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |