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

Device Problem Device Stops Intermittently (1599)

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.(b)(6).

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue.There was no additional information available for this complaint.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 06/10/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/23/2016 with the following findings: a review of the black box revealed unexplained "power on reset" events on 03/08/2016 and 03/11/2016.The battery compartment was found to be intact.The battery cap width and height measurements were within specifications.The battery cap tightly secured to the pump.The pump was powered on with the returned battery cap.The pump was exercised with the returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated.The pump case was removed; there was no evidence of moisture or loose components found inside the pump.The "intermittent power" complaint was not duplicated during investigation.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: 5551869
• MDR Text Key: 42498294
• Report Number: 2531779-2016-07278
• 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: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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: 05/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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