FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2081602
·
Received April 13, 2011
Report
- Report Number
- 2531779-2011-02528
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ANIMAS CORP.
- 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. ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. IT WAS FOUND THAT THE SYMBOLS WERE WORN OFF THE KEYPAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UP, DOWN, AND OK BUTTONS ARE INCREASINGLY UNRESPONSIVE TO PRESSES. IT WAS REPORTED THAT THE PUMP IS NOT EXPOSED TO WATER AND THERE IS NO KEYPAD PEELING. IT WAS REPORTED THAT THE SYMBOLS ARE WORN OFF THE KEYPAD.
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 |