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

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The pump has not been returned to animas.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, animas received a phone call from a medical examiner(me) requesting an investigation report on a deceased patient¿s vibe pump.Per the me, the alleged cause of death is suicide, and the me is trying to determine if the patient administered additional insulin by the pump or with supplies within her possession.There is no allegation of a malfunction against the pump at this time.This complaint is being reported because there was a death reported and potential misuse of the pump by the patient.
Additional Manufacturer Narrative
Follow-up #1: date of submission 25-sep-2019.Device evaluation: the device has been returned and evaluated by product analysis on 24-sep-2019 with the following findings: during investigation, the pump passed all required testing for delivering accuracy.The pump history and the black box did not show any evidence of a delivery malfunction and the basal totally daily dose (tdd) matched the programmed basal rate.The continuous glucose monitor (cgm) session was not active and the actual blood glucose (bg) was unable to be captured at the time.The allegation of an other/unusual issue was not duplicated or confirmed during investigation.There was no defect found.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.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 LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9097763
• Report Number: 2531779-2019-04781
• Device Sequence Number: 16851883
• Product Code: OYC
• UDI-Device Identifier: 10840406103168
• UDI-Public: 10840406103168
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR