FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2040008
·
Received March 25, 2011
Report
- Report Number
- 2531779-2011-01923
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- ANIMAS CORP
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE UP AND DOWN ARROW KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE UP AND DOWN ARROW KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UP AND DOWN ARROW BUTTONS WERE INCREASINGLY UNRESPONSIVE TO PRESSES. IT WAS REPORTED THAT THE PUMP IS NOT EXPOSED TO WATER AND THE KEYPAD IS NOT DAMAGED.
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 |