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

Medical Device Problem Code	Pumping Problem (3016)
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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that the pump was slowing down.The reporter was unable to complete troubleshooting at the time of the call.This complaint is being reported because it is possible that the alleged issue might cause a problem with insulin delivery.There was no serious injury associated with this complaint.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 03-oct-2018 with the following findings: the pump was exercised for 12 hours with no issues occuring.Investigation found no defect related to original complaint of pump slowing down.Unable to verify or duplicate reported issue.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7901502
• Report Number: 2531779-2018-17347
• Device Sequence Number: 16581262
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 09/06/2018

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: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR