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
The device 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.Each cartridge lot is subjected to a statistical sampling plan and must pass testing for force (occlusion and loss of prime), cracks, and foreign material prior to release for distribution.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas alleging an issue with loss of prime two times within one week.No further information was provided and the reporter was not able to troubleshoot the issue with animas customer technical support (cts).Cts attempted to contact the reporter again multiple times to complete the troubleshooting of the issue, but the reporter did not respond.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
The primary product involved in the complaint has been clarified by the reporter during follow up communications; the primary product was determined not to be the insulin cartridge, but rather the infusion set.Animas does not manufacture the infusion set therefore no regulatory report is required.Animas will forward the complaint to the relevant manufacturer.Please consider this complaint completed/closed.

• 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: 8473421
• Report Number: 2531779-2019-02309
• Device Sequence Number: 1253308
• Product Code: LZG
• UDI-Device Identifier: 10840406100129
• UDI-Public: 10840406100129
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 03/29/2019

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: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 34