MAUDE Adverse Event Report: ANIMAS LLC 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 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) 2019, the reporter contacted animas, alleging a button/keypad (tactile changes/unresponsive) issue; all keypad button are allegedly under responsive.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the issue can result in inadvertent or incorrect insulin delivery or the inability to use the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 29-mar-2019 with the following findings: on examination, the keypad cover was intact and without damage.On testing, all the keypad buttons were unresponsive.Investigation duplicated the complaint.There was no damage, defect or contamination of the button contacts.Unrelated to the original complaint, there was visible moisture in the display screen due to moisture ingress into the pump at the site of a crack in the battery case.Leak testing confirmed moisture leakage into the interior compartment of the pump causing moisture damage to the printed circuit board, including the keypad flex (wiring).Investigation concluded unresponsive keypad buttons due to moisture damage.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8436971
• Report Number: 2531779-2019-02026
• Device Sequence Number: 14015610
• Product Code: OYC
• UDI-Device Identifier: 10840406100082
• UDI-Public: 10840406100082
• 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,Followup
• Report Date (Section B): 03/18/2019

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: 03/25/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 46 MO
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR