FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1893856
·
Received November 1, 2010
Report
- Report Number
- 2531779-2010-02064
- Event Type
- Malfunction
- Date Received
- November 1, 2010
- Report Date
- October 2, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED SWOLLEN, THE PUMP WAS INTERMITTENTLY RESPONSIVE TO ALL KEYPAD BUTTONS, THE UP KEY CONTACT WAS MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE OK BUTTON HAS TO BE PRESSED VERY HARD FOR THE PUMP TO RESPOND. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER. 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 |