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

Device Problems Moisture Damage (1405); Temperature Problem (3022)

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.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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a temperature (temp-moisture ingress) issue.Reportedly the pump had a temperature issue after exposure to bath water and there was moisture/corrosion in the pump.The reporter denied any physical damage to the pump.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 07/13/2016 with the following findings: a review of the black box indicated a sudden voltage drop had occurred leading to a ¿low battery¿ warning on (b)(6) 2016.Visual inspection revealed that the battery compartment was cracked and there was moisture/corrosion in the battery compartment and on the battery cap.Leak testing revealed a battery compartment leak.The pump powered on and successfully completed rewind, load, and prime steps.Sleep current draws were found to be above specifications, however no overheating was duplicated on investigation.The pump cover was removed and further moisture corrosion was observed on the printed circuit board and on the continuous glucose monitor module.Unrelated to the original complaint, investigation revealed that the display was dim and discolored.

• 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: 5659065
• MDR Text Key: 45414088
• Report Number: 2531779-2016-10058
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/31/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 28 MO
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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
• Patient Age: 28 YR