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

Device Problems Failure to Read Input Signal (1581); Inaccurate Delivery (2339)

Patient Problems Blurred Vision (2137); Ambulation Difficulties (2544)

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 experienced a hypoglycemic event while on the pump.The reporter stated that the patient had a blood glucose between 24 mg/dl and 30 mg/dl with symptoms of blurred vision and unsteadiness.The patient did not receive any treatment above and beyond the normal course of diabetes management.The patient had remained on the pump at the time of the call.The reporter alleged that the pump's up and down keypad buttons were under responsive.The reporter stated that this issue caused an over delivery of insulin to the patient.This complaint is being reported based on the allegation that the patient experienced a hypoglycemic event as a result of tactile changes to the keypad buttons.

Manufacturer Narrative

Follow-up #1: date of submission 02/02/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/12/2017 with the following findings: the pump's black box showed an unexplained pump reboot event on (b)(6) 2016 at 16:48; deliveries resumed at 16:57.An unexplained pump reboot was also observed on (b)(6) 2016 at 17:12; deliveries never resumed.The recorded total daily doses added up correctly and reflected the user's programmed basal rates.The keypad was intact.The pump was returned with moisture behind the display lens.The entire keypad was unresponsive.Internal moisture damage was found on the keypad flex connector.

• 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: 5868353
• MDR Text Key: 51847524
• Report Number: 2531779-2016-20253
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100044
• UDI-Public: 0110840406100044
• 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: 07/20/2016

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: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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): Life Threatening
• Patient Age: 38 YR