FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1901623
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02223
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Report Date
- October 12, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE SWOLLEN, THE PUMP WAS INTERMITTENTLY RESPONDING TO KEYPAD BUTTON PRESSES, THE BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE, THE UP KEY CONTACT WAS MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED AND MISALIGNED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THAT ALL KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT PUMP DOES NOT ALWAYS RESPOND TO THE KEYPAD BUTTON PRESSES. THE PUMP REPORTED HAS NOT BEEN EXPOSED TO WATER AND THE KEYPAD IS INTACT. 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 |