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

Medical Device Problem Codes	Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and evaluated by product analysis on 08/07/2017 with the following findings: a review of the black box history showed multiple call service 087 alarms.The issue was duplicated during power up.The call service 069 failure was written to the black box as a call service 087 failure.Investigation revealed that a language corruption occurred at a component on the printed circuit board resulting in a call service alarm.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue.It was reported that there was a 069 call service alarm.There was no indication that this issue lead to an adverse event.This is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

• 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: 6793565
• Report Number: 2531779-2017-18265
• Device Sequence Number: 130455
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 0110840406100358
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: 02/28/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1