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U.S. Department of Health and Human Services

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

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ANIMAS CORP. ANIMAS INSULIN INFUSION PUMP   Back to Search Results
Model Number IR 1250
Event Date 02/20/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

The pt was hospitalized for hypoglycemia and seizure.

 
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.

 
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Brand NameANIMAS INSULIN INFUSION PUMP
Type of DeviceINSULIN 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 Key986968
MDR Report Key1018843
Event Key977574
Report Number2531779-2008-00158
Device Sequence Number1
Product CodeLZG
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 Received03/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberIR 1250
Device Catalogue NumberIR 1250
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/03/2008
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/21/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2007
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

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