MAUDE Adverse Event Report: ANIMAS LLC 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
Device evaluation: the device has been returned and evaluated by product analysis on 01-oct-2018 with the following findings: the keypad was found to be fully intact; no peeling or damage was observed.During testing, all of the keypad buttons were found to respond appropriately.The keypad cover was opened and there was no evidence of contamination found under any of the key contacts.The pump cover was opened, and there was a display lens leak.There was evidence of moisture and corrosion on the keypad connector, and on the display board.The original complaint of keypad button response issue was unable to be duplicated during investigation.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a button/keypad (tactile changes w/moisture) issue.It was reported that the up arrow, down arrow, and ok/enter buttons were under-responsive and that moisture was located behind the display.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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7926328
• Report Number: 2531779-2018-17720
• Device Sequence Number: 11193082
• Product Code: OYC
• UDI-Device Identifier: 10840406100228
• UDI-Public: 10840406100228
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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
• Report Date (Section B): 09/16/2018

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: 09/26/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 27 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR