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 06/21/2016

Event Type  Injury  

Manufacturer Narrative

The pump has not been returned to animas at the time of this report.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, a reporter contacted animas alleging that a patient was hospitalized with hyperglycemia while on the pump.The reporter stated that the patient had a blood glucose over 500 mg/dl with diabetic ketoacidosis.The reporter stated that the patient had discontinued pump therapy at the time of the call.The reporter was unable to provide details as to what the patient was being treated with while they were hospitalized, but did state that the patient was being admitted to the intensive care unit.The reporter was able to review some of the pump's history and settings with a customer technical support representative.The review found that the basal delivery totals in the recorded total daily dose did not match up with each other, but this variation was due to a known cause.The reporter stated that the patient had made changes to the basal program, the prime menu had been accessed, and the pump had been suspended at some point.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event and had to be hospitalized as a result of an inaccurate delivery of insulin.

• 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: 5799551
• MDR Text Key: 49743414
• Report Number: 2531779-2016-16367
• 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
• Report Date: 06/21/2016

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: 011084040610005121520056716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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: 22 YR