FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1031261
·
Received April 18, 2008
Report
- Report Number
- 2531779-2008-00215
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 17, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED DAMAGE TO THE SEAL IN THE PUMP HOUSING BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.
Description of Event or Problem · 1
THE PATIENT 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 1200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |