MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS INSULIN CARTRIDGE; INSULIN PUMP CARTRIDGE

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump has not been returned to animas.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.
Event or Problem Description
On (b)(6) 2016, the reporter contacted animas alleging the patient was vomiting at time of the call.A 911 protocol reportedly was initiated.The pump reportedly had a no delivery message-pump not primed message.Animas customer technical support reportedly attempted to contact the reporter multiple times without resolve.There was no additional information available for this complaint.This complaint is being reported because the patient experienced an adverse event allegedly due to a loss of prime issue with the device.
Additional Manufacturer Narrative
Follow-up #1; date of submission: 11/23/2016.

• Brand Name: ANIMAS INSULIN CARTRIDGE
• Common Device Name: INSULIN PUMP CARTRIDGE
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6108997
• Report Number: 2531779-2016-31663
• Device Sequence Number: 10853482
• Product Code: LZG
• UDI-Device Identifier: 10840406100822
• UDI-Public: 0110840406100822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 30 YR
• Patient Weight: 57