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

Device Problems Filling Problem (1233); Failure to Prime (1492); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

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

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

The pump has not been requested for return at this time.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 04/19/2016 the reporter contacted animas alleging that on the same date, the patient was hospitalized for elevated blood glucose (bg) over 400mg/dl with large ketones associated with a prime issue.The patient was reportedly treated with insulin via injection and remained on the pump.Troubleshooting indicated that the patient was priming inconsistent prime volumes; a review of the pump history showed one prime volume of 1.3units and another of 4.7units.Additionally, the pump histories showed three fill cannula amounts of 0.0units.This complaint is being reported based on the allegation that the patient experienced hyperglycemia requiring medical intervention associated with use error of the pump铠prime and fill cannula functions.

• 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: 5636982
• MDR Text Key: 44609356
• Report Number: 2531779-2016-09356
• 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: 04/19/2016

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?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610006821257443516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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: 9 YR