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

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Manufacturer Narrative

The pump 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, it was reported that a loss of 5 minutes per month occurred.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because a time change during use, without user intervention, may result in the user running the incorrect basal segment leading to over or under delivery.

Manufacturer Narrative

Follow-up #1: date of submission: 03/22/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/28/2017 with the following findings: evaluation revealed the internal clock battery on the pcb had failed.The pump would not retain the user programmed date and time settings upon removal of the primary aa battery.When a new aa battery is inserted the pump displays the default date and time which must be manually confirmed (or reset) by the user in order to proceed.Unrelated to the original complaint, the battery compartment was observed to be cracked.

• 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: 6236282
• MDR Text Key: 64636125
• Report Number: 2531779-2017-00704
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100075
• UDI-Public: 0110840406100075
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: 01/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 21 MO
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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: 215