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 06/08/2016

Event Type  Injury  

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

The reporter contacted animas on (b)(6) 2016 alleging that on (b)(6) 2016.The patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring >500 mg/dl and positive urinary ketones.The reporter stated that patient was hospitalized with the diagnosis of diabetic ketoacidosis and was treated for the same with an undisclosed treatment plan.The reporter alleged an inaccurate delivery issue with the insulin pump; the basal history did not match the active basal program.Animas customer support attempted to contact the health care provider (hcp) for clarification of the event; however, was unable to reach the hcp.This complaint is being reported because the patient reportedly experienced a serious injury requiring hospitalization while on insulin pump therapy alleging the pump failed to deliver accurately.

Manufacturer Narrative

Follow-up #1: date of submission 07/25/2016.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.Device evaluation: the device has been returned and evaluated by product analysis on 07/18/2016 with the following findings: review of the black box data revealed an unexplained loss of prime event on (b)(6) 2016 at 16:58 followed by ¿power on reset.¿ power to pump was restored (b)(6) 2016 at 16:51.The pump was then manually suspended on (b)(6) 2016 at 16:52 and delivery by the pump was never resumed.On investigation, the pump was powered on and exercised for 24 hours on a 2.0 unit/hour basal rate program.At the conclusion of the exercise, the basal history correctly reflected 2.0 units and the total daily dose showed 48.0 units delivered.The total daily doses added up correctly to reflect the user¿s programmed basal rates.The pump passed delivery accuracy testing without delivery defects.The pump was found to be delivering accurately and within the required range.No delivery interruptions, errors, alarms or warnings occurred during the investigation.Investigation did not duplicate the complaint.(b)(4).

• 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: 5732063
• MDR Text Key: 47598003
• Report Number: 2531779-2016-12247
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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: 07/06/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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