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

Device Problem Retraction Problem (1536)

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 motor (rewind issue) issue.The reporter alleged the pump would not complete the rewind step.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because if the pump is unable to complete the rewind step, the patient may experience long-term session of insulin delivery leading to under delivery of insulin.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 03-may-2019 with the following findings: review of the black box data did not reveal any activity outside of normal use.The returned battery cap was intact, without damage and able to fit securely to pump.On investigation, the pump powered on normally and ez-prime steps were successfully completed.All electrical current readings were within specification.Rewind, load and prime steps were completed without issue.The pump was exercised for 24 hours without error, alarm, warning, interruption in power or overheating.There was no damage, defect or contamination of the pump's interior components.Investigation did not duplicate the complaint.

• 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: 8522333
• MDR Text Key: 142255459
• Report Number: 2531779-2019-02678
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• 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: 04/13/2019

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: 04/18/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Initial Date Manufacturer Received: 04/13/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/13/2019
• Supplement Dates FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 170