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

Medical Device Problem Codes	Moisture Damage (1405); 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 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 button/keypad (tactile changes w/moisture) issue.It was reported that the up arrow, down arrow, and ok buttons were under-responsive and that moisture/corrosion was located in the ir window.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.
Additional Manufacturer Narrative
Follow-up #1: date of submission: 10/02/2017.Device evaluation: the device has been returned and evaluated by product analysis on 09/05/2017 with the following findings: the pump was returned with moisture visible in the battery compartment.There was no evidence of moisture observed behind the ir window.The keypad cover was intact; no damage was observed.All of the keypad buttons were found to be intermittently unresponsive to button presses.The keypad cover was removed and there was no moisture or contamination was found under the button contacts.The pump was opened and there was moisture found on the keypad flex-connector and throughout the pump casing.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: 6769985
• Report Number: 2531779-2017-17541
• Device Sequence Number: 149480
• Product Code: OYC
• UDI-Device Identifier: 10840406100365
• UDI-Public: 0110840406100365
• 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): 07/13/2017

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: 08/24/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 41