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 07-aug-2019, the reporter contacted animas, alleging a call service alarm (cs 078) issue.It was alleged that a call service alarm [078] 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.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 21-aug-2019 with the following findings: a review of the pump¿s black box and alarm history showed evidence of a call service 078 alarm.During investigation, the pump was powered on and there was no motor movement and the call service 078 was duplicated with the rewind, load and prime steps.Unrelated to the original complaint, the pump cover was removed and there was evidence of moisture under the display lens and on the motor flex connector and surrounding components, including the sound device.A leak test was conducted and a leak was found at the display lens.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8898025
• Report Number: 2531779-2019-04368
• Device Sequence Number: 1617310
• Product Code: OYC
• UDI-Device Identifier: 10840406100242
• UDI-Public: 10840406100242
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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): 08/07/2019

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: 08/20/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 35 MO
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR