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

Device Problems Electrical /Electronic Property Problem (1198); 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 power (damage) issue.It was alleged that the battery cap was unable to be removed from the pump and there was no power.There was no indication that the product caused or contributed to an adverse event.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 02/15/2017 with the following findings: a review of the black box showed no power issues.No damage was found to the battery compartment.The complaint of a difficult to remove battery cap was duplicated.The battery cap was stripped and would not attach securely to a test pump.A test battery cap was able to attach securely and remove with out difficulty.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours with a test cap and no power issues occurred.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• 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: 6216701
• MDR Text Key: 63821122
• Report Number: 2531779-2016-35134
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100051
• UDI-Public: 0110840406100051
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/08/2016
• 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: 22 YR