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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue.No details were provided.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported as there is an allegation against the delivery function of the pump.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 12/19/2016 with the following findings: a review of the pump histories indicated that the last bolus and last basal deliveries occurred on (b)(6) 2016.A review of the black box indicated the following: an ¿exceeded max 2 hour limit¿ warning occurred on (b)(6) 2016 at 19:24 and deliveries resumed at 20:03; an unexplained loss of prime warning occurred on (b)(6) 2016 at 09:04, the pump was powered off, and deliveries resumed on (b)(6) 2016 at 15:57.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 issues occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.No delivery interruptions and no errors, alarms, or warnings occurred during investigation.(b)(4).

• 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: 6081914
• MDR Text Key: 59575813
• Report Number: 2531779-2016-30694
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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