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

Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to animas.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 occlusion (frequent/persistent) issue.The reporter was not able to provide further information during the initial complaint.Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success.There was no indication that the product caused or contributed to an adverse event.This 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.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 21-sep-2018 with the following findings: during investigation, the black box and pump history for the day of the event were overwritten.There were no occlusion alarms observed in the available pump history.The rewind, load cartridge, and prime steps were performed successfully with no alarms.The pump was detecting the correct force.The pump exercised for 12 hours with no occlusions occurring.The pump¿s cover was removed, no intermittent condition was found to the force sensor circuit.

• 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: 6043578
• MDR Text Key: 57981276
• Report Number: 2531779-2016-29221
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100198
• UDI-Public: 0110840406100198
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• 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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 MO
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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: 29 YR
• Patient Weight: 242