FDA Adverse Event
Injury
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1231623
·
Received November 13, 2008
Report
- Report Number
- 2531779-2008-00787
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 17, 2008
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION DEMONSTRATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERY ACCURACY.
Description of Event or Problem · 1
PT'S FATHER REPORTS HOSPITALIZATION DUE TO ELEVATED BLOOD GLUCOSE LEVELS AND DKA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONE TOUCH PING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |