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 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), 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.
Additional Manufacturer Narrative
Follow-up #1: the device has been returned and evaluated by product analysis on 11-nov-2017 with the following findings: a review of the pump¿s black box and alarm history showed a call service 069 alarm, which is written in the pump's black box as cs87.During testing, a hard call service 69 alarm was reproduced at the rewind step.The cs 069 failure is defined as a language file corruption while retrieving the language text.The language corruption issue causing the cs69 alarm was found to be due to a malfunction in the u39 flash chip, a component on the printed circuit board.

• 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: 6978829
• Report Number: 2531779-2017-24824
• Device Sequence Number: 16267878
• Product Code: OYC
• UDI-Device Identifier: 10840406100099
• UDI-Public: 0110840406100099
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/07/2017

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: 11/02/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/07/2017
• Supplement Date Received by Manufacturer: 10/07/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 200