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

Device Problem Occlusion Within Device (1423)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)

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 the patient experienced hyperglycemia with blood glucose measure =250 mg/dl with large urinary ketones and vomiting.The patient was reportedly hospitalized and treated by health care providers.The reporter stated that the patient experienced the hyperglycemic event associated with frequent/persistent occlusion of the insulin pump.The occlusion was reported to have occurred on (b)(6) 2016 at 18:27 and involved more than one infusion set.During troubleshooting with animas customer technical support, the pump was not able to be primed without experiencing occlusion.The insulin cartridge was determined to be used per instructions for use.This issue is being reported because the occlusion issue remained unresolved and the patient reportedly experienced an adverse physical event associated with the occlusion issue.

Manufacturer Narrative

Follow-up #1: date of submission 12-aug-2019.Device evaluation: the device has been returned and evaluated by product analysis on 06-aug-2019 with the following findings: according to the pump history, the pump was in use until 10-apr-2017 with no additional occlusions recorded.The complaint regarding occlusions was reported to occur on 5-mar-2016.The pump alarm history verified 5 occlusion alarms on 5-mar-2016 between 1:50 am and 06:56 am.During investigation, the pump passed all required testing including delivery accuracy and force sensor testing with no defects found.There were no occlusions duplicated during investigation the 12 hour duration test.The complaint of an occlusion issue was shown in the history but was not duplicated during investigation.Unrelated to the complaint, investigation revealed that the display was dim and discolored.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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• 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: 5494830
• MDR Text Key: 40144938
• Report Number: 2531779-2016-05660
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• 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: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 28 MO
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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: 20 YR