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

Device Problem No Audible Alarm (1019)

Patient Problems Hyperglycemia (1905); Nausea (1970); Confusion/ Disorientation (2553); Lethargy (2560)

Event Type  Injury  

Manufacturer Narrative

The pump has been returned to animas.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 and alleged the following: patient states the pump did not alert for a blood glucose was above the limit from 9:26pm until 5:56am, when a glucose rise rate warning was received.Her snooze time is set for 90 minutes, and she did not receive an alarm all night.Patient had a blood glucose of 367 mg/dl, with confusion, lethargy, and nausea, but received no unusual treatment.Patient's medical history includes high blood pressure, a sleep disorder, and fibromyalgia.This complaint is being reported as the patient experienced hyperglycemia when the alert was not emitted.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 05/17/2017 with the following findings: during investigation the last basal delivery was on (b)(6) 2016.The total daily dose added up correctly and reflected the programmed basal rate target.The pump reflected the 24 unit after 24 hours on a 1 unit/ hr duration.The product delivered within specification.The complaint could not be confirmed during testing and the investigation concluded with no defects found to the pump.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: 5678526
• MDR Text Key: 45883238
• Report Number: 2531779-2016-10485
• 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: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610008221939874916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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 Age: 69 YR