FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING
MDR report key: 1952660
·
Received January 3, 2011
Report
- Report Number
- 2531779-2011-00021
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Report Date
- December 6, 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 EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED, THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE BOLUS BUTTON WAS DIFFICULT TO PUSH AND INTERMITTENTLY RESPONSIVE TO USER INPUT DURING TESTING, ALL KEYPAD BUTTONS WERE RESPONSIVE AND SPRUNG BACK WHEN PRESSED, AND IT WAS OBSERVED THAT THE BOLUS BUTTON KEY CONTACT ACTIVATOR WAS ROTATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE AUDIO BOLUS BUTTON IS INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. THE PTS CLAIMED THAT THE KEYPAD BUTTON STILL SPRING UP AND DOWN AND CLICK NORMALLY. THE PT DENIED TEARS OR PEELING OF THE KEYPAD. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONE TOUCH PING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |