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

Device Problems Failure to Prime (1492); Inaccurate Delivery (2339)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: investigators were unable to confirm or duplicate the alleged issue.The black box data and pump history have been overwritten due to continued use of the pump.There was no evidence of a load step malfunction in the available black box data.The ezprime sequence was successfully completed with no issues.The force sensor was performing per normal operation - detecting the correct force.Unrelated to the original complaint, the battery compartment was cracked in two places.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a prime (load step malfunction) issue.The reporter alleged that the pump was priming tubing during the load step.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is potential for insulin over-delivery if the patient is not disconnected during the load cartridge step.The owner's booklet provides a warning to the user to never start the prime/rewind sequence on the pump while the infusion set is connected to the body and provides multiple reminders during the prime/rewind sequence.

• 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: 5848981
• MDR Text Key: 52553002
• Report Number: 2531779-2016-19006
• 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
• Report Date: 07/13/2016

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
• Other Device ID Number: 011084040610004421395389616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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
• Patient Age: 60 YR
• Patient Weight: 210