MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas for evaluation.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) 2017, the reporter contacted animas, alleging a casing/condition (damaged cap and case)- unable to remove battery cap issue.There was no indication the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction can result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
Additional Manufacturer Narrative
Follow-up #1: date of submission 10/19/2017 - device evaluation: the pump has been returned and evaluated by product analysis on 09/25/2017 with the following findings: during investigation, the alleged original complaint of a damaged battery compartment could not be duplicated.Further investigation revealed the threads of the battery compartment cap were stripped and there was difficulty tightening the cap to the pump.A test battery cap was used and could attach and remove with no issues.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6769610
• Report Number: 2531779-2017-17496
• Device Sequence Number: 13634627
• Product Code: OYC
• UDI-Device Identifier: 10840406100617
• UDI-Public: 0110840406100617
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• 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): 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR