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 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 that the pump delivered insulin inaccurately.During troubleshooting with customer technical support, all of the pump's basal and bolus history added up to reflect the programmed rates and deliveries.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is an allegation against the delivery function of the pump.

Manufacturer Narrative

Follow-up #1 date of submission 12/06/2016-correction to describe event or problem: information was received from the reporter indicating that there was no malfunction of the pump, and the alleged issue was one related to use error.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 4/04/2017 with the following findings: a review of the pump histories showed multiple manual suspends and manual resumes performed on the pump.A review of the total daily dose history indicated that the insulin delivery totals correctly reflected the programmed basal rate targets.The pump¿s ¿ez-prime¿ steps were performed correctly.The pump passed a delivery accuracy test and was found to be operating within required specification and delivery accurately.No defects were found on investigation therefore the investigation was unable to duplicate the initial ¿inaccurate delivery¿ complaint.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.(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: 6130956
• MDR Text Key: 61232620
• Report Number: 2531779-2016-32342
• 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: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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: 03/29/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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 Age: 3 YR