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

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no health consequence to the patient associated with the reported incident, and no medical treatment or health care provider intervention was required.Therefore, there is no healthcare provider information to report.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas alleging the pump had been losing prime since the customer got the pump.No further information was available.Troubleshooting was not completed.Animas customer support made several attempts to contact the reporter in follow-up however, the customer was not able to speak with customer support regarding the alleged loss of prime issue.There is no indication the alleged product issue 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 submitted: 11-feb-2019.Animas customer support received new, additional information from the reporter on 10-feb-2019 indicating the primary product associated with the alleged loss of prime issue is the insulin pump, not the cartridge.A complaint associated with the insulin pump has been completed and submitted to the fda under medwatch report #(b)(4) on animas (b)(4) on 11-feb-2019.Please refer to that report for the loss of prime update.The insulin cartridge has been determined to the secondary product, not the primary product.

• Brand Name: ANIMAS INSULIN CARTRIDGE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8302250
• Report Number: 2531779-2019-00858
• Device Sequence Number: 13491288
• Product Code: LZG
• UDI-Device Identifier: 10840406100129
• UDI-Public: 10840406100129
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K032257
• 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): 01/30/2019

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
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR