FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1870443
·
Received October 6, 2010
Report
- Report Number
- 2531779-2010-01468
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Report Date
- September 6, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE PT NOTICED THAT THE "OK" BUTTON WAS DIFFICULT TO PUSH SEVERAL WEEKS AGO WHEREAS THE OTHER BUTTONS WORK W/O ANY DIFFICULTIES. THE PT REPORTED NO CUTS IN THE KEYPAD, THAT IT FELT LIKE SOMETHING WAS LOOSE UNDER THE KEYPAD, THERE WAS NO WATER EXPOSURE, AND NO CLEANING PRODUCTS WERE USED ON THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |