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

Device Problems No Display/Image (1183); Structural Problem (2506)

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 display (damaged) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up # 1 date of submission 2/19/2017.Device evaluation: the device has been returned and evaluated by product analysis on 1/25/2017 with the following findings: during visual inspection of the pump, it was observed that the pump was returned with a shattered display screen and the display film lens was scratched in multiple areas.During testing, the pump powered up with auditory and vibration alerts to a blank display screen.Due to the blank display the investigation was unable to verify some steps of the investigation.A test display screen was mounted onto the pump and it was fully illuminated and functional.Unrelated to the original complaint, it was observed that the battery compartment was cracked.Unrelated to the initial complaint, it was observed that the battery compartment was cracked and the audio bolus button cover was damaged.The investigation was unable to verify the audio bolus button¿s response to user input due the blank screen.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.

• 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: 6134020
• MDR Text Key: 61294820
• Report Number: 2531779-2016-32425
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100341
• UDI-Public: 0110840406100341
• 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: 11/01/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 16 YR