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 other (unusual issue) issue.The reporter alleged the pump will emit a low battery warning and the user will change out the battery and the low battery warning will re-appear again.During troubleshooting with animas customer support, the alarm history in the pump was reviewed and there were no low battery warnings in the history as the reporter alleged.The reporter then alleged that all low battery warnings that were emitted from the pump from (b)(6) 2019, to the current time were not recorded in the pump's alarm history after the user confirmed the warning.During troubleshooting, the pump emitted a low battery warning and it was correctly recorded in the pump's alarm history as expected.This complaint is being reported because the issue may result in a long-term cessation of insulin delivery due to unexpected power loss if the user is unable to resolve the alleged low battery warning recording error issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 31-jul-2019 with the following findings: during investigation, there was no data in pump histories from time of reported issue due to continued use.A low battery warning was induced during testing.Low battery warning was accurately recorded in pump history.Unable to duplicate or verify reported issue.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: 8271077
• Report Number: 2531779-2019-00686
• Device Sequence Number: 16664306
• Product Code: OYC
• UDI-Device Identifier: 10840406100280
• UDI-Public: 10840406100280
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 01/22/2019

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: 7 MO
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR