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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Vomiting (2144); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553); Polydipsia (2604)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas and alleged that on (b)(6) 2016, the patient experienced a blood glucose (bg) value of 850 mg/dl with a large level of ketones, nausea, blurred vision, confusion, abdominal pain, extreme drowsiness, extreme thirst, and vomiting associated with an issue related to the suspend feature of the pump.Reportedly, the patient was hospitalized and received treatment from the health care provider, including intravenous fluids and insulin via injection, which was above and beyond the routine treatment of diabetes.The patient allegedly remained on insulin pump therapy.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with the suspend setting issue.

Manufacturer Narrative

Follow-up #1: date of submission 06/23/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/07/2016 with the following findings: the pump's black box from the date of the event had been overwritten due to continued use of the pump.The available pump history showed that the pump was manually suspended on (b)(6) 2016 at 22:37.The pump was powered off for an unknown reason while suspended; the next recorded prime was on (b)(6) 2016 at 12:48.A rewind, load and prime sequence were successfully completed with no issues.The pump was exercised for a 24 hour duration period; no self-suspending occurred during this time period.No hypersensitive keys were observed on the keypad.The pump was able to be manually suspended and manually resumed with no issues.The daily insulin delivery totals correctly reflected the user's programmed basal rates.The pump passed a delivery accuracy test and was found to be delivering within the required range.The alleged issue could not be duplicated during the 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.

• 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: 5689013
• MDR Text Key: 46217588
• Report Number: 2531779-2016-10744
• 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: 05/10/2016

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: 011084040610002021949004116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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: 41 YR