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

Medical Device Problem Code	Pumping Problem (3016)
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) 2019, the reporter contacted animas, alleging a history/settings (history/settings issue) issue.It was reported that the user ¿had some issues with pump that caused them to reach the max limits.¿ the patient did not want to discuss issue.The patient wanted assistance with changing max limit due to total daily dose (ttd) warning.Customer technical support provided assistance and confirmed with no further assistance needed.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8887291
• Report Number: 2531779-2019-04355
• Device Sequence Number: 19466392
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/04/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR