FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1050282
·
Received May 22, 2008
Report
- Report Number
- 2531779-2008-00277
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 21, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 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. | ANIMAS 2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |