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

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405)

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 (moisture ingress) issue. It was reported that the pump had no power. There was no damage reported to the battery compartment or battery cap; the yellow o-ring was not visible at the battery cap. There was moisture observed in the pump. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

• 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: 6034733
• MDR Text Key: 57721639
• Report Number: 2531779-2016-28818
• 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
• Report Date: 09/25/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 43 MO
• Event Location: No Information
• Date Manufacturer Received: 09/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown