FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1060463
·
Received June 13, 2008
Report
- Report Number
- 2531779-2008-00340
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 11, 2008
- Report Date
- May 15, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED COSMETIC SCRATCHES TO THE DISPLAY LENS BUT DEMONSTRATED THAT PUMP WAS INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECS AND DELIVERY ACCURACY.
Description of Event or Problem · 1
THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 1250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |