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  

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 a other (unusual issue) issue.The patient stated that when the bolus was trying to be given, the screen would freeze and the only way to unfreeze it was to lock and unlock the pump immediately.This issue will occur intermittently.There is no indication that the product issue caused or contributed to an adverse event.The complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.

Manufacturer Narrative

Follow-up # 1 date of submission 3/09/2017 device evaluation: the device has been returned and evaluated by product analysis on 2/14/2017 with the following findings: a review of the pump¿s black box and download history did not find any activity related to the complaint.During testing, the pump powered on with normal auditory and vibration alerts.During visual inspection of the pump, it was observed that there was no physical damage to the pump.The pump¿s ¿ez-prime¿ steps were performed correctly and no alarms, errors or warnings occurred during the 24 hour duration test.It was observed that the bolus button was operating properly and the button cover was intact.The investigation was unable to verify or duplicate the initial complaint.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.(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: 6230501
• MDR Text Key: 64342935
• Report Number: 2531779-2017-00515
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100365
• UDI-Public: 0110840406100365
• 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: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• 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: 01/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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: 13 YR
• Patient Weight: 60