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 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 call service alarm issue.It was reported that the pump emitted a cs 069 call service alarm.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because this issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
Additional Manufacturer Narrative
Date of submission (b)(4) 2017 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2017 with the following findings: a review of the pump¿s black box and alarm history confirmed a cs 069 alarm, which is written in the pump's black box as cs87.The pump was powered on and a hard cs69 alarm was shown and could not be reset.The cs69 alarm was found to be caused by a u39 flash chip.Unrelated to the original complaint, the battery compartment was found to be cracked below the grip pad.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• 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: 6960488
• Report Number: 2531779-2017-24113
• Device Sequence Number: 1291265
• Product Code: OYC
• UDI-Device Identifier: 10840406100037
• UDI-Public: 0110840406100037
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/21/2017

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: 10/02/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR