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

Medical Device Problem Codes	Structural Problem (2506); 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 device has been returned and evaluated by product analysis on 05-aug-2019 with the following findings: during investigation, the pump alarmed with a call service (cs 069) during power up.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.Unrelated to the original complaint, the battery compartment was found to be cracked.
Event or Problem Description
On 03-aug-2019, the reporter contacted animas and reported that call service alarm [069] had been emitted by the pump more often than expected by the user.There was no indication that the product caused or contributed to an adverse event.This complaint 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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8911342
• Report Number: 2531779-2019-04411
• Device Sequence Number: 16297995
• Product Code: OYC
• UDI-Device Identifier: 10840406100075
• UDI-Public: 10840406100075
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2019

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: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 41 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR