FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2080070
·
Received April 6, 2011
Report
- Report Number
- 2531779-2011-02295
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Report Date
- March 9, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE UP ARROW, DOWN ARROW AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE UP ARROW, DOWN ARROW AND CONTRAST KEYPAD CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UP AND DOWN ARROWS ARE INTERMITTENTLY UNRESPONSIVE. IT WAS REPORTED THE PUMP IS NOT EXPOSED TO WATER AND THE KEYPAD IS NOT 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 |