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

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 05/08/2016, the reporter contacted animas, alleging a history/settings (history/settings issue) issue; the reporter alleged that the pump "kept reverting back to suspend." this complaint is being reported because 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.There was no indication that the product caused or contributed to an adverse physical event.

Manufacturer Narrative

Follow-up #1: date of submission 06/22/2016: device evaluation: the device has been returned and evaluated by product analysis on 06/09/2016 with the following findings: review of the pump history revealed the pump was suspended on the date of the reported issue.On investigation, the pump was exercised for 24 hours without self suspending or any alarms occurring.As part of the investigation, the pump was suspended; the pump gave the appropriate audio and visual suspend alert associated with the suspension.On examination, there was no damage found to the keypad and all buttons responded to presses appropriately.Investigation did duplicate the complaint.

• 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: 5662054
• MDR Text Key: 45502382
• Report Number: 2531779-2016-10124
• Device Sequence Number: 1
• Product Code: MDS
• 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: 05/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610005121126604416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Date Manufacturer Received: 05/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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: 60 YR