FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1881326
·
Received October 18, 2010
Report
- Report Number
- 2531779-2010-01728
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Report Date
- September 18, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD WAS TORN NEAR THE OK AND DOWN ARROW BUTTONS, THE PUMP WAS UNRESPONSIVE TO THE DOWN ARROW AND OK BUTTONS, AND THE DOWN ARROW AND OK BUTTONS WERE INVERTED.
Description of Event or Problem · 1
THE PUMP IS REPORTEDLY INTERMITTENTLY RESPONDING WHEN THE BUTTONS ARE PRESSED, THE BUTTONS ARE STICKING, AND THE KEYPAD IS TORN.
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 |