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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue.There was no additional information available for this complaint.There was no indication that the product caused or contributed to an adverse event.This complaint is reportable as there is an allegation against the delivery function of the pump.

Manufacturer Narrative

Follow-up #1: date of submission 05/25/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/06/2016 with the following findings: the last basal delivery was on (b)(6) 2016.The pump history revealed that the pump was manually suspended on (b)(6) 2016 at 10:37 and manually resumed at 10:46.The last bolus delivery was a 0.65 unit bolus on (b)(6) 2016 at 10:49.The total daily insulin delivery correctly reflected the user's programmed basal rates.The pump passed the delivery accuracy test and was found to be delivering within required range and delivering accurately.There were no delivery interruptions or any errors, alarms or warnings that occurred during the investigation.The reported inaccurate delivery complaint was unable to be duplicated during testing.Unrelated to the complaint, the battery compartment was found to be cracked on the side from the threads to cover.

• 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: 5605789
• MDR Text Key: 44177220
• Report Number: 2531779-2016-08456
• 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
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

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: 04/28/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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