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

Device Problem Noise, Audible (3273)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

The pump 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 that on an unspecified date, the patient experienced elevated blood glucose (bg) of "high" (>600mg/dl) with no reported signs or symptoms of hyperglycemia.Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and discontinued insulin pump therapy.The reporter noted that the pump's motor was making a grinding noise and was loud during the rewind and prime steps.The reporter stated that they felt the issue was impacting insulin delivery.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a motor issue.

Manufacturer Narrative

Follow-up #1: date of submission 07/28/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/07/2016 with the following findings: a review of the pump histories did not find any errors, alarms, or warnings associated with the complaint.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.Multiple rewind, load, and prime steps were performed successfully with no motor noises occurring.The pump was exercised for 24 hours with no issues occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.The pump cover was removed and no internal defects were found.The complaint could not be confirmed or duplicated on investigation.

• 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: 5768927
• MDR Text Key: 48743549
• Report Number: 2531779-2016-14555
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610035821590370116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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: 13 YR
• Patient Weight: 67