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

Device Problem Inaccurate Delivery (2339)

Patient Problems Headache (1880); Hyperglycemia (1905); Dizziness (2194); Confusion/ Disorientation (2553)

Event Type  malfunction  

Manufacturer Narrative

The product 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) 2016, the reporter contacted animas alleging a blood glucose of 5.8 mmol/l with dizziness, confusion, and a headache related to an inaccurate delivery issue.The patient reportedly self treated the blood glucose with oral carbohydrates.The reported blood glucose does not meet animas criteria for an adverse event.Troubleshooting of the event was unable to be completed at the time of contact.Animas attempted to follow up with the reporter but has been unsuccessful at this time.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no adverse event associated with this complaint.

Manufacturer Narrative

Follow up #1 09/22/2016.Device evaluation: the pump has been returned to animas and evaluated on 08/27/2016 with the following findings: the last recorded basal and bolus deliveries were on (b)(4) 2016.The recorded total daily doses of insulin correctly added up to the expected amount.The pump passed a delivery accuracy test and was found to be delivering within the required range.There were no delivery interruptions or alarms observed during the investigation.The alleged issue could not be duplicated.

• 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: 5577981
• MDR Text Key: 43165469
• Report Number: 2531779-2016-07852
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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: 36 YR