FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2161862
·
Received July 14, 2011
Report
- Report Number
- 2531779-2011-04939
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON 06/15/2011. (B)(6). 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO HAVE AN INTERMITTENT CONNECTION AT THE FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY SHOWED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURED WHICH WAS NOT DUPLICATED DURING TESTING.
Description of Event or Problem · 1
DURING EVALUATION, AN INTERMITTENT CONNECTION WAS FOUND AT THE FORCE SENSOR PINS.
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 | 67 |