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

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to animas.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) 2017, the reporter contacted animas and alleged the patient had a blood glucose (bg) 40 mg/dl with "things getting black" blurry vision, unsteadiness, and confusion.The patient required assistance and was treated with glucose gel/tablets.The patient alleged an inaccurate delivery issue and was not able to complete troubleshooting the pump.This complaint is being reported as the patient experienced hypoglycemia and the pump was not able to be eliminated as a cause/contributor.

Manufacturer Narrative

The device was returned and evaluated by product analysis on 02/02/2017 with the following findings: review of the pump¿s black box indicated no abnormal pump behavior.The total daily dose history was appropriate for the user programmed delivery settings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The pump passed a delivery accuracy test.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: 6262695
• MDR Text Key: 65208576
• Report Number: 2531779-2017-01532
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100211
• UDI-Public: 0110840406100211
• 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: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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: 01/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 63 YR
• Patient Weight: 120