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 been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion 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 there was moisture behind the display and no power in the pump. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up # 1 date of submission 12/08/2016. Device evaluation: the device has been returned and evaluated by product analysis on 11/09/2016 with the following findings: during the investigation, that pump could not be powered on. The attempt to download the pump history and black box was unsuccessful due to internal moisture damage. The pump failed the 24 hour basal program due to having no power. It was observed that the audible and vibratory alarms were inoperable. During visual inspection of the pump, it was observed that the battery compartment and the returned battery cap were undamaged. The returned battery cap was able to attach securely to the pump. Unrelated to the initial complaint, it was observed that the pump case was cracked between the case seal and the keypad. A leak test was performed and failed due to leaks at the crack in the pump case. It was also observed that there was moisture in the display. The pump was opened and there was moisture damage found on the printed circuit board (pcb). The loss of power issue was duplicated during this investigation.

• 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: 6052102
• MDR Text Key: 58497887
• Report Number: 2531779-2016-29556
• 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: 10/04/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/24/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: No Information
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown