FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1023276
·
Received April 1, 2008
Report
- Report Number
- 2531779-2008-00179
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 29, 2008
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS IS CURRENTLY CONDUCTING AN EVALUATION OF A CARTRIDGE FROM THIS MANUFACTURING LOT. THIS EVALUATION HAS NOT YET BEEN COMPLETED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. THE PATIENT REPORTED THAT THE CARTRIDGE COMPARTMENT EXHIBITED MOISTURE. THE PATIENT ALSO REPORTED THAT NO INSULIN BOLUSES WERE ADMINISTERED FOR 24 HOURS PRIOR TO THE HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | IR 1200/1250/2020 | B201161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |