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

Medical Device Problem Code	Failure to Read Input Signal (1581)
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 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 button/keypad (tactile changes/unresponsive) issue; all buttons under responsive.Patient was reportedly swimming with pump just prior to the keypad button issue.This complaint is being reported because the issue can result in inadvertent or incorrect insulin delivery or the inability to use the pump.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
Follow-up #1: date of submission 09/27/2017 device evaluation: the device has been returned and evaluated by product analysis on 08/28/2017 with the following findings: during investigation, the original complaint of the unresponsive keypad was unable to be duplicated.The keypad cover was undamaged and all the buttons were responsive.The keypad cover was opened and there were no contaminants found under the contacts.The pump was opened and there was no intermittent condition found on the keypad flex connector.Unrelated to the original complaint, the battery compartment was cracked.

• 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: 6759266
• Report Number: 2531779-2017-16841
• Device Sequence Number: 11135736
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 0110840406100358
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/06/2017

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: 07/20/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR