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

Device Problems Moisture Damage (1405); Failure to Read Input Signal (1581)

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 button/keypad (tactile changes w/moisture) issue.This complaint is being reported because the reported issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 09/19/2016.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.Device evaluation: the device has been returned and evaluated by product analysis on 08/26/2016 with the following findings: on investigation, the keypad cover was intact and without damage.On testing, all the keypad buttons had normal response.The keypad cover was removed for investigation and revealed no contamination on the contacts of the keypad buttons.Investigation did not duplicate the complaint of under responsive down/ok buttons.On inspection, there was evidence of moisture behind the display lens.Leak testing failed due to a leak at a crack between the case seal and the corner of the display lens.Investigation confirmed the moisture complaint.The pump was opened for further investigation and revealed moisture contamination throughout the interior compartment of the pump; moisture was on the main printed circuit board, the inside cover, the keypad flex connector and the transceiver.Pump download was not possible due to the moisture damage.The battery compartment was also noted to be cracked below the bumper pad traveling toward the case seal.

• 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: 5864056
• MDR Text Key: 52844757
• Report Number: 2531779-2016-19785
• 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: 07/20/2016

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: 08/17/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 24 MO
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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
• Patient Age: 17 YR