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

Medical Device Problem Codes	No Display/Image (1183); Moisture Damage (1405)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a display (cloudy w/ moisture) issue.It was noted that there was moisture within the battery compartment.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(6) 2017 device evaluation: the device has been returned and evaluated by product analysis on ((b)(6) 2017 with the following findings: during investigation, the pump was powered on and the display was found to be functioning properly.Unrelated to the original complaint, a crack was observed in the battery compartment.A leak test was performed and a leak was identified at the crack in the battery compartment.The pump was opened and no further moisture damage was found.The original complaint of a cloudy display could not be duplicated during investigation.

• 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: 6704878
• Report Number: 2531779-2017-14397
• Device Sequence Number: 1157477
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 0110840406100358
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/13/2017

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: 07/09/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 107