FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2042887
·
Received March 30, 2011
Report
- Report Number
- 2531779-2011-02061
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- December 1, 2011
- Report Date
- March 1, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
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. EVAL REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE CONTRAST BUTTON IS UNRESPONSIVE, AND THE OK AND THE UP AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST FEW MONTHS. HE DENIED PEELING OF THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT THE PT WEARS THE PUMP IN HER POCKET.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |