FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1883863
·
Received October 23, 2010
Report
- Report Number
- 2531779-2010-01875
- Event Type
- Malfunction
- Date Received
- October 23, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 24, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO UP AND DOWN ARROW BUTTON PRESSES. THE OK BUTTON WAS ALSO OBSERVED TO BE HYPERSENSITIVE AND WOULD NOT CLICK OR SPRING BACK. ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE UP, DOWN AND OK BUTTON CONTACT. THE OK BUTTON CONTACT WAS FOUND TO BE INVERTED.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO OK AND DOWN ARROW BUTTON PRESSES. THE PT DENIED THAT THE KEYPAD WAS PEELING.
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 | 32 YR |