FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1901573
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02204
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 10, 2010
- Report Date
- October 10, 2010
- Manufacturer
- ANIMAS CORP.
- 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 BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS NOT RESPONDING TO UP, DOWN, AND OK KEYPAD BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. IN ADDITION, THE BUTTON CONTACTS WERE OBSERVED TO BE INVERTED AND WERE NOT SPRINGING BACK. ALSO, THE UP AND DOWN BUTTON CONTACTS WERE MISALIGNED. THE KEYPAD ALSO APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. MOISTURE WAS OBSERVED THROUGH THE DISPLAY LENS. A LAST TEST REVEALED A KEYPAD LEAK. THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO BUTTON PRESSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |