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

Device Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

The pump 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) 2016, the reporter contacted animas and alleged the pump had an inaccurate delivery issue, starting on (b)(6) 2016.The patient developed a blood glucose (bg) in the 50mg/dl's for which they were treated in the er and released.The low bg was preceded by a correction bolus given approximately 3 hours prior required.The patient is currently under a bg management plan.This complaint is being reported as the patient required emergency room treatment for a bg related to an alleged inaccurate delivery issue.

Manufacturer Narrative

Follow-up #1: date of submission 14-jun-2019.Device evaluation: the device has been returned and evaluated by product analysis on 12-jun-2019 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten due to continuous use.The available daily insulin delivery totals correctly reflected the programmed basal rates.The pump history showed the pump was delivering the programmed basal rate until deliveries were halted by the user.The pump passed delivery accuracy testing and was found to be delivering within the 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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 5741181
• MDR Text Key: 47909766
• Report Number: 2531779-2016-12712
• Device Sequence Number: 1
• Product Code: MDS
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610006821440224616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: 05/25/2016
• Supplement Dates FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 24 YR