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

Device Problems Inaccurate Delivery (2339); High Test Results (2457)

Patient Problems Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Polydipsia (2604)

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) up to 350mg/dl with blurred vision, nausea, thirst, and light headedness.Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and remained on the pump.The reporter stated that the patient was under increased stress but was unwilling to rule out the pump; the reporter alleged that the patient did not feel the pump was delivering insulin accurately.The reporter noted that the patient's uncle had died, the patient's aunt was on life support, and the patient's spouse was in the emergency room.Additionally, the reporter noted that the patient had a history of multiple previous strokes.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with alleged insulin delivery issue.

Manufacturer Narrative

Follow-up #1: date of submission 07/12/2006.Device evaluation: the device has been returned and evaluated by product analysis on 06/29/2016 with the following findings: a review of the black box indicated that the last basal and last bolus deliveries occurred on (b)(6) 2016.The black box showed an occlusion alarm at 23:53 on (b)(6) 2016 and deliveries resumed on (b)(6) 2016 at 05:43.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.The pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours with no errors, alarms, or warnings occurring.A 10 unit audio bolus and a 10 unit normal bolus were successfully completed with no issues.The pump passed delivery accuracy testing and was found to be delivering within required specifications.The complaint could not be confirmed or duplicated on investigation.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: 5737728
• MDR Text Key: 47824879
• Report Number: 2531779-2016-12480
• 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: 05/26/2016

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: 011084040610008221288182316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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 Outcome(s): Life Threatening
• Patient Age: 48 YR