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.There was reportedly moisture and corrosion behind the display.There was no indication of damage to the pump.There was no indication that the product caused or contributed to an adverse event.This is reportable because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up #1: date of submission 10/04/2016.Device evaluation: the device has been returned and evaluated by product analysis on 09/08/2016 with the following findings: moisture was observed under the display lens.A cracked battery compartment was observed below the grip pad to the case seal.A leak test failed due to battery compartment leak.The pump was opened; moisture damage was found on display, continued glucose module board, printed circuit board and keypad flex connector.Unrelated to the complaint, the display was dim with reddish text.Also unrelated to the complaint, all of the keypad buttons were unresponsive; however, the keypad cover was found to be intact.The keypad cover was opened; there was no contamination found under the contacts.

• 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: 5896041
• MDR Text Key: 52746198
• Report Number: 2531779-2016-22447
• 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: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• 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: 08/25/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 29 MO
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• 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