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 that the a1 weekday basal setting was completely erased following a battery change.There was no indication that the product caused or contributed to an adverse event.This issue is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 04/10/2017 with the following findings: the pump powered on normally and successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours on a 1.0 unit per hour basal rate.No errors, alarms, or warnings occurred during investigation.After 24 hours, the battery was removed to simulate a battery change; when the battery was reinserted in the pump, the basal program remained programmed as expected.The complaint could not be confirmed or duplicated on investigation.Unrelated to the original complaint, investigation revealed that the battery compartment was cracked.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: 6261260
• MDR Text Key: 65522537
• Report Number: 2531779-2017-01495
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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: 04/03/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Date Manufacturer Received: 12/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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: 35 YR