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) 2018, the reporter contacted animas, alleging a other (unusual issue) issue.It was reported that the pump was not working properly or delivering insulin.The reporter also alleged that the pump kept beeping.Customer technical support was unable to troubleshoot at the time of the call as it was also reported that the pump was unavailable as it was lost.There was no allegation of an adverse event with this complaint.This complaint is being reported based on the allegation against the delivery function of the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 28-jan-2019 with the following findings: a review of the black box showed the auto off alarm was set to enable for 13 hours.The pump alarmed auto off causing a delivery interruption.During investigation, the pump passed all delivery accuracy testing.The pump history and black box showed no evidence of pump malfunctions related to delivery functions.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8032883
• Report Number: 2531779-2018-19075
• Device Sequence Number: 1435537
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 10840406100020
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 10/24/2018

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: 01/21/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 37 MO
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR