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

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Diabetic Ketoacidosis (2364)

Event Date 12/07/2015

Event Type  Death  

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 01/25/2016, animas was notified that the patient was deceased.The reporter indicated that the patient was hospitalized for diabetic ketoacidosis with a blood glucose over 1000 mg/dl while wearing the pump.The reporter indicated that the patient was experiencing elevated blood glucose levels while wearing the vibe insulin pump however, the patient had not changed the site or treated with an insulin injection.The reporter indicated that the patient was treated for diabetic ketoacidosis and discharged from the hospital.Two days after the patient was discharged from the hospital, the patient suffered a cardiac event and passed away.It is unclear if the patient was using or attached to the pump at the time of the cardiac event.No additional information was available related to the event.This report is made based on the indication that the patient was hospitalized and subsequently passed away and the use of the insulin pump could not be ruled out as a contributor to the event.

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 22-jan-2018 with the following findings: a review of the black box showed an unexplained power on reset event, and the pump was powered on by the user but a prime was not performed to resume deliveries.The first basal program totaled 10.2 units per day and the second basal program was programmed with a total of 0.625 units per day.The black box showed multiple call service 163 and 165 max total daily dose limit warnings with deliveries resumed.The returned battery cap tightened securely to the pump with no power losses or reboots.The force sensor measured within specifications, and the auditory and vibratory alarms were functional.The pump passed delivery accuracy testing with no delivery defects.The pump was delivering accurately and within range.The pump cover was removed to find no internal moisture or force sensor defects.The history settings issue was unable to be duplicated during investigation.

• 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: 5442364
• MDR Text Key: 38407376
• Report Number: 2531779-2016-04063
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610007521558833316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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): Death; Hospitalization; Life Threatening
• Patient Age: 47 YR