FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1894863
·
Received November 5, 2010
Report
- Report Number
- 2531779-2010-02155
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS NOT RESPONDING TO BOLUS BUTTON PRESSES. THE BOLUS BUTTON WAS REMOVED AND OBSERVED TO BE OFF CENTERED.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO BUTTON PRESSES. THE PT CLAIMED THAT WHENEVER SHE PRESSED THE BUTTONS, THE PUMP WOULD VIBRATE AND SOUND AS THOUGH THE MOTOR WAS REWINDING ALTHOUGH NOTHING WOULD APPEAR ON THE SCREEN. THE PT DENIED THAT THE PUMP WAS EXPOSED TO WATER.
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 | 58 YR |