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 device 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 power (moisture ingress) issue.It was alleged that there was moisture behind the display and there was intermittent power.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission 11/06/2017 device evaluation: the device has been returned and evaluated by product analysis on 10/12/2017 with the following findings: a review of the black box showed evidence of unexplained power on reset events on the date of the complaint.The pump powered on with the returned battery cap to an audible tone and vibration alert, with a blank display.The battery cap was within specifications, and was able to fully tighten to the pump.The pump case was removed to find moisture contamination throughout the inside of the pump.The blank display was due to moisture ingress.The intermittent power complaint was not duplicated during the investigation.Unrelated to the original complaint, the battery compartment was cracked below the grip pad with no evidence of 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: 6777296
• Report Number: 2531779-2017-17869
• Device Sequence Number: 1039001
• Product Code: OYC
• UDI-Device Identifier: 10840406100303
• UDI-Public: 0110840406100303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/18/2017

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: 08/08/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR