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

Device Problems Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

On (b)(6) 2019, the reporter contacted animas, alleging a call service alarm (cs 064) issue.It was reported that the pump emitted multiple cs 064 call service alarms.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because this issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 14-jan-2020 with the following findings: a review of the pump¿s black box and alarm history showed evidence of a call service 064 alarm.During testing, the pump successfully completed the rewind, load, and prime steps without any call service alarms, warnings or issues.The pump successfully delivered a 10 unit normal bolus during testing without any issue or call service alarms.The pump cover was removed and there was evidence of moisture damage to the motor flex connector and surrounding components.The original complaint of a call service alarm issue was noted in the pump history but unable to be duplicated during investigation.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 9529828
• MDR Text Key: 173038043
• Report Number: 2531779-2019-06183
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406103199
• UDI-Public: 10840406103199
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 130