MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; 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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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.It was reported that the pump repeatedly emitted loss of prime warnings despite cartridge changes.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because it 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: the device has been returned and evaluated by product analysis on 10/12/2017 with the following findings: a visual inspection of the cartridge was performed with no damage or defects noted.A fill test, and force test were performed and no failures were observed.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.
Additional Manufacturer Narrative
Follow-up #2: the pump has been returned and evaluated by product analysis on 15-nov-2017 with the following findings: a review of the black box showed multiple loss of prime warnings with low zero and non zero forces.The pump was run for 24 hours and the loss of prime issue was not duplicated.The force calibration testing passed.The pump was opened to find moisture on the force sensor plate.Unrelated to the original complaint, the battery compartment was cracked from the case seal to the grip pad.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6921764
• Report Number: 2531779-2017-23133
• Device Sequence Number: 1354698
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• Combination Product (Y/N): N
• 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: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2017

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 21 MO
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 09/14/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/31/2017; 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR