FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2123847
·
Received June 14, 2011
Report
- Report Number
- 2531779-2011-04159
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 2, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.
Description of Event or Problem · 1
DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |