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

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 02/13/2016

Event Type  Injury  

Manufacturer Narrative

The product 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 alleging a hospitalization for diabetic ketoacidosis with a blood glucose of 28-30 mmol/l associated with inaccurate delivery of insulin.The reporter was treated with insulin via injection and intravenous fluids.This report is made based on the allegation that the patient was hospitalized for diabetic ketoacidosis associated with inaccurate insulin delivery.

Manufacturer Narrative

Follow-up #1 04/12/2016 device evaluation: the pump has been returned and evaluated by product analysis on 03/30/2016 with the following findings: a review of the total daily dose history showed that the daily insulin delivery totals correctly reflected the user programmed basal rates.The pump was manually suspended on (b)(6) 2016 at 03:24 and was resumed at 10:08.The pump was suspended again on (b)(6) 2016 at 16:26 and the pump deliveries were not resumed.A delivery accuracy test was performed and the pump was found to be delivering within specifications.No delivery related defects were found during testing.

• 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: 5451654
• MDR Text Key: 38714004
• Report Number: 2531779-2016-04323
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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; Life Threatening
• Patient Age: 56 YR