FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1982577
·
Received January 12, 2011
Report
- Report Number
- 2531779-2011-00185
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR INVESTIGATION. EVALUATION CONFIRMED THAT THE PUMP RESET TO THE DEFAULT TIME DURING A BATTERY CHANGE. DURING INVESTIGATION, THE FAILURE WAS CONFIRMED; THE PUMP WAS UNABLE TO HOLD THE DATE/TIME AND HAD RESET ITSELF TO THE DEFAULT TIME DUE TO A LEAKING BT1 (INTERNAL BATTERY).
Description of Event or Problem · 1
THE PATIENT'S MOM INDICATED THAT THE BATTERY WAS REPLACED IN THE PUMP AND THE DATE/TIME SETTING WAS CORRECTED. AT AN UNSPECIFIED TIME AFTER THE DATE/TIME SETTING WAS SET, THE PUMP'S TIME SETTING WAS CHANGED WITHOUT USER INTERVENTION. THERE WAS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THE PUMP WAS REPLACED.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |