FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2031799
·
Received March 21, 2011
Report
- Report Number
- 2531779-2011-01764
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. DURING INVESTIGATION, IT WAS FOUND THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE UP ARROW, DOWN ARROW AND OK KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW AND OK BUTTONS ARE UNRESPONSIVE. IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO WATER AND THERE IS NO KEYPAD 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 |