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

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to animas.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) 2018, the reporter contacted animas, alleging a history/settings (history/settings issue) issue.It was alleged the bolus feature was malfunctioning.The reporter was not able to provide further information during the initial complaint.Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there was an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.

Manufacturer Narrative

Follow-up #1: date of submission (b)(4) 2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2018 with the following findings: a review of the pump history showed the last bolus delivery was recorded on (b)(4) 2018 at 4:09 pm.The total daily dose basal history recorded the date of (b)(4) 2018 twice and appeared to be inaccurate because of the time/date not being set correctly by the user after a pump reboot at (b)(4) 2018 at 3:35 pm.During investigation, the pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 12 hours with no issues occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7599615
• MDR Text Key: 111469803
• Report Number: 2531779-2018-10872
• Device Sequence Number: 1
• Product Code: OYC
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: 11/12/2018
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 13 YR