MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS INSULIN CARTRIDGE; INSULIN PUMP CARTRIDGE

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 pump has been returned to animas for evaluation.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) 2017, the reporter contacted animas, alleging a prime (loss of prime) issue.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.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
Follow-up #1: date of submission 04/20/2017.Device evaluation: the device has been returned and evaluated by product analysis on 03/30/2017 with the following findings: during investigation, there was one unexplained loss of prime observed in the black box.The force reading was zero.The rewind, load and prime steps were performed successfully with no alarms.The force sensor calibration test confirmed the force sensor was detecting the correct for.The pump was exercised for 24 hours with no loss of prime occurring.The pump was opened and there was no damage found to the force sensor circuit.
Additional Manufacturer Narrative
Correction: upon review of the complaint, it has been determined that the product is the cartridge.

• Brand Name: ANIMAS INSULIN CARTRIDGE
• Common Device Name: INSULIN PUMP CARTRIDGE
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6348291
• Report Number: 2531779-2017-04073
• Device Sequence Number: 13753085
• Product Code: LZG
• UDI-Device Identifier: 10840406100594
• UDI-Public: 0110840406100594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2017

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: 02/13/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 04/20/2017; 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR