FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1140998
·
Received August 27, 2008
Report
- Report Number
- 2531779-2008-00529
- Event Type
- Injury
- Date Received
- August 27, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 25, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP, AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. PUMP SETTINGS AND DELIVERY HISTORY WERE REVIEWED WITH THE PATIENT'S CDE AND CONFIRMED AS ACCURATE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. 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.
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 |