FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2113695
·
Received June 3, 2011
Report
- Report Number
- 2939301-2011-04563
- Event Type
- Malfunction
- Date Received
- June 3, 2011
- Report Date
- May 11, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE MISSING RESULTS COULD NOT BE CONFIRMED WITH TESTING. HOWEVER, THE LCD SCREEN WAS NOTED TO BE DAMAGED/CRACKED DURING A VISUAL INSPECTION. 510K # 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 ALLEGEDLY HAS A CRACKED DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3114491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |