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

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2016, the reporter contacted animas alleging that the pump has malfunctioned multiple times with error codes.There was no allegation of an adverse event with this complaint.Customer support has made several attempts to contact the reporter in follow up, however, the reporter did not respond.No further information was available; if further information is provided a follow up report shall be mad.This complaint is being reported based on the allegation of a non-specific pump malfunction.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 05/19/2017 with the following findings: review of the black box revealed records of call service alarms (088, 054, 052).The pump powered on normally for investigation.The pump was successfully primed and exercised for 24 hours without call service alarms occurring.The pump was opened for further investigation and did not reveal any evidence of damage, defect or contamination of the pump¿s internal components.The alleged call service alarms were confirmed in the pump history, but not duplicate during investigation.The pump performed as intended without malfunction.(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: 6269127
• MDR Text Key: 65779435
• Report Number: 2531779-2017-01859
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100082
• UDI-Public: 0110840406100082
• 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,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2017
• 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: 05/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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: 54 YR
• Patient Weight: 235