FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1984045
·
Received January 12, 2011
Report
- Report Number
- 2531779-2011-00235
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Report Date
- December 14, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER THE UP/DOWN/OK BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUT, AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
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 |