FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1893665
·
Received November 2, 2010
Report
- Report Number
- 2531779-2010-02040
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS OBSERVED TO BE SWOLLEN. THE BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND THE 'UP' AND 'DOWN' BUTTON CONTACTS WERE FOUND TO BE MISALIGNED. ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR PAST FEW WEEKS. REPORTS HAS TO PRESS BUTTON MULTIPLE TIMES TO GET RESPONSIVE AT TIMES. PUMP NOT EXPOSED TO MOISTURE.
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 | 30 YR |