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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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 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 power (moisture ingress) issue.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
Follow-up #1: date of submission 11-jan-2018.Device evaluation: the device has been returned and evaluated by product analysis on 19-dec-2017 with the following findings: during investigation, the pump powered up with the returned battery cap to auditory and vibratory alarms to a blank display.The battery cap fully tightened to the pump, and measured within specifications.No cracks were found in the battery compartment or moisture.A leak was found in the display lens.The pump case was removed to find evidence of moisture contamination throughout the inside of the pump.The blank display was due to moisture contamination.The black box and pump history were unable to be downloaded due to the internal moisture.

• 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: 6984639
• Report Number: 2531779-2017-25097
• Device Sequence Number: 10794849
• Product Code: OYC
• UDI-Device Identifier: 10840406100327
• UDI-Public: 0110840406100327
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR