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

Medical Device Problem Codes	Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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 call service alarm (call service alarm issue) issue.It was alleged a call service 069 alarm and another unknown alarm occurred.There was no indication that this issue lead to an adverse event.This is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 29-mar-2019 with the following findings: a review of the black box data and alarm history revealed cs 087 and 064, 078 call service alarms had occurred.During investigation, the pump alarmed with a call service (cs 069) during power up.Due to the cs 069 call service alarm that would not clear, the 078, 064 alarms were unable to be investigated.The call service 69 failure was written to the black box as a call service 87 failure.A language corruption occurred at a component on the printed circuit board resulting in a call service alarm.A leak test was performed and leaks were found in a pump case crack.The pump was opened and there was moisture observed on the motor flex connector, transceiver board, and in the battery compartment.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8395955
• Report Number: 2531779-2019-01718
• Device Sequence Number: 18880105
• Product Code: OYC
• UDI-Device Identifier: 10840406100068
• UDI-Public: 10840406100068
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 03/21/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 39 MO
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/06/2019
• 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: 31 YR
• Patient Weight: 200