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

Medical Device Problem Codes	Partial Blockage (1065); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump 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) 2018, the reporter contacted animas, alleging a occlusion (frequent/persistent) issue.It was reported that occlusion alarms occurred with four different sets of new infusion sets and cartridges.There was no indication that the product caused or contributed to an adverse event.This complaint 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: date of submission (b)(4) 2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2018 with the following findings: during investigation, there were multiple occlusion alarms observed in the black box; the force at time of occlusions is high.The rewind, load cartridge, and prime steps performed successfully with no alarms.Force sensor calibration test confirmed sensor is detecting correct force at 5lbs.No occlusions occurred during testing.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8009448
• Report Number: 2531779-2018-18821
• Device Sequence Number: 16185356
• Product Code: OYC
• UDI-Device Identifier: 10840406103106
• UDI-Public: 10840406103106
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2018

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: 10/22/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Initial Date Received by Manufacturer: 10/13/2018
• Supplement Date Received by Manufacturer: 10/13/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR