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

Device Problems Inaccurate Delivery (2339); High Test Results (2457)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970); Tachycardia (2095); Vomiting (2144); Dizziness (2194); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)

Event Date 06/17/2016

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 alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose of 603mg/dl with diabetic ketoacidosis, nausea, vomiting, dizziness, confusion, rapid heart rate, abdominal pain, and large ketones.The patient reportedly discontinued insulin pump therapy and was treated with insulin via injection and intravenous fluids.The reporter alleged that the pump was not delivering enough basal insulin, which resulted in the hospitalization.Troubleshooting could not be completed at the time of the complaint.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a basal delivery issue.

Manufacturer Narrative

Follow-up #1: date of submission 09/25/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/25/2016 with the following findings: a review of the black box indicated an unexplained reboot at 05:18 on 06/17/2016; when the pump was powered back on, the time was set incorrectly to 02:33.The black box showed a ¿replace cartridge¿ alarm at 13:28 on (b)(6) 2016 followed by a reboot at 14:40; deliveries were resume 02:23 (b)(6) 2016.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.The pump powered on normally and successfully completed rewind, load, and prime steps.The pump was exercised for 24 hours on a 2.0 unit per hour basal rate.At the end of testing, the basal history correctly showed 2.0 units per hour and the total daily dose history showed a total of 48.0 units.The pump passed delivery accuracy testing and was found to be delivering within required specifications.No errors, alarms, or warnings and no delivery interruptions occurring during investigation.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.(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: 5825452
• MDR Text Key: 50520112
• Report Number: 2531779-2016-17511
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

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: 011084040610006821866302516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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; Required Intervention
• Patient Age: 16 YR