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

Device Problem No Display/Image (1183)

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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a display (blank screen with/moisture) issue.The reporter alleged moisture behind the display.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 09/06/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/10/2016 with the following findings: during investigation, the pump was unable to be powered on to verify the original complaint of a blank display.The power failure caused product analysis to be unable to test the keypad responsiveness, the clarity of the display, and the auditory and vibratory alarms.During a visual inspection of the pump a battery compartment crack was found alongside the pump.This caused a leak to occur.The pump was opened and corrosion was found in the battery compartment, and moisture damage was present on the printed circuit board.Due to the moisture damage the pump was unable to power on.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.

• 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: 5794044
• MDR Text Key: 50319831
• Report Number: 2531779-2016-16134
• 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: 06/24/2016

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
• Other Device ID Number: 011084040610008221156345516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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: 59 YR