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

Device Problem 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 casing/condition (moisture ingress) issue.It was reported that moisture was present behind the display.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported as the alleged malfunction has the ability to result in a delay in treatment or long term cessation of insulin delivery if the damage impacts the power circuit or cartridge cap.

Manufacturer Narrative

Follow-up #1: date of submission 09/16/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/23/2016 with the following findings: evidence of moisture was noted in the battery compartment and behind the display lens.A leak test failed due to a battery compartment leak.The pump was opened up and evidence of moisture was found on the transceiver board and on the force sensor plate.Unrelated to the original complaint, the battery compartment was noted to be cracked in two places.

Manufacturer Narrative

The pump has not been returned to animas for evaluation.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.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.Correction: serial # (b)(4).

• 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: 5864017
• MDR Text Key: 52847545
• Report Number: 2531779-2016-19765
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100051
• UDI-Public: 0110840406100051
• 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,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 08/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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
• Patient Weight: 137