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

Medical Device Problem Code	Device Issue (2379)
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 (history/settings issue) issue.It was alleged that the pump the contrast button was pressed to unlock the pump, and the pump continued to the home screen and it did not act as a shortcut for the continuous glucose monitoring.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there was an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07/06/2017 with the following findings: the vibe user manual states ¿pressing the contrast button while the pump is in sleep mode will awaken the pump to one of the cgm trend graphs or the cgm data screen¿.The contrast button on the vibe pump will not act a ¿cgm shortcut¿ while the pump is in locked mode; the pump needs to be in ¿sleep¿ mode for this feature to work.The pump was paired with a test transmitter for testing purposes.The ¿cgm data screen¿ was correctly accessed by pushing the contrast button while the pump was in sleep mode.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• 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: 6539495
• Report Number: 2531779-2017-09239
• Device Sequence Number: 10949997
• Product Code: OYC
• UDI-Device Identifier: 10840406100327
• UDI-Public: 0110840406100327
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 04/11/2017

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: 06/23/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 55