MAUDE Adverse Event Report: ANIMAS CORP.ANIMAS INSULIN INFUSION PUMP

Model Number IR 1250

Event Date 02/20/2008

Event Type  Injury   Patient Outcome  Hospitalization

Manufacturer Narrative

The pump has not been returned to animas for evaluation. Evaluation demonstrated that the pump was operating within required specifications and delivery accuracy.

Event Description

The pt was hospitalized for hypoglycemia and seizure.

• Brand Name: ANIMAS INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section F): ANIMAS CORP.; 200 lawrence dr.; west chester PA 19380
• Manufacturer (Section D): ANIMAS CORP.; 200 lawrence dr.; west chester PA 19380
• Manufacturer Contact: laurie rauco, sr. analyst ; 200 lawrence dr.; west chester , PA 19380; (610) 644 -8990
• Device Event Key: 986968
• MDR Report Key: 1018843
• Event Key: 977574
• Report Number: 2531779-2008-00158
• Device Sequence Number: 1
• Product Code: LZG
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: UNKNOWN
• Type of Report: Initial
• Report Date: 02/21/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/24/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device MODEL Number: IR 1250
• Device Catalogue Number: IR 1250
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2008
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 02/21/2008
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Unkown