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

Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump 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.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a history/settings (suspend) issue.This complaint is being reported because suspending or resuming of the pump without an alarm may result in over or under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission: 26-jan-2018.Device evaluation: the device has been returned and evaluated by product analysis on 04-jan-2018 with the following findings: a review of the pump¿s black box and alarm history showed evidence of multiple manual suspend alerts.During testing, the pump successfully completed the rewind, load, and prime steps without any interruptions or issues.The pump successfully completed the 24 hour duration test without interruptions or issues.The pump was manually suspended, resumed correctly, and adequately recorded the suspend event in the pump history.The original complaint of a pump suspend issue was unable to be duplicated.There was no defect found.

• 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: 7156749
• Report Number: 2531779-2018-00009
• Device Sequence Number: 1213934
• Product Code: OYC
• UDI-Device Identifier: 10840406100099
• UDI-Public: 10840406100099
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/05/2017

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: 12/15/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 23 MO
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 150