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

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has not been returned to animas for evaluation.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.(b)(6).

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging that there were loss of prime warnings.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

(b)(4).Follow-up #1: date of submission 03/15/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/24/2017 with the following findings: review of the black box data revealed loss of prime warnings recorded 24 oct 2016.On testing, the force sensor was found to be within specifications.Loss of prime was not duplicated during investigation.Unrelated to the original complaint, the audio bolus button was inoperable due to the button slug being missing; complete pump testing was not able to be performed due to the inoperable audio bolus button.Additionally, unrelated to the original complaint, the battery compartment was noted to be cracked.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.Follow-up #1: date of submission 03/15/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/24/2017 with the following findings: review of the black box data revealed loss of prime warnings recorded 24 oct 2016.On testing, the force sensor was found to be within specifications.Loss of prime was not duplicated during investigation.Unrelated to the original complaint, the audio bolus button was inoperable due to the button slug being missing; complete pump testing was not able to be performed due to the inoperable audio bolus button.Additionally, unrelated to the original complaint, the battery compartment was noted to be cracked.

• 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: 6278268
• MDR Text Key: 65941724
• Report Number: 2531779-2017-02134
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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: 01/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/29/2016
• 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