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

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The pump has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.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.No conclusions can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging that the pump had lost power.Reportedly, there were no damages to the battery compartment or cap and the cap was able to fasten properly.No evidence of moisture corrosion in the pump was noted.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: 05/17/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/03/2016 with the following findings: review of the black box data did not reveal any evidence of power on reset events.On examination, the battery cap and battery compartment were intact without damage.On investigation, the battery cap was fastened and then unscrewed ½ turn with no reboots occurring.¿ez-prime¿ steps were performed correctly.No power interruption occurred during investigation.The pump cover was removed for investigation and did not reveal any evidence of damage, defect or contamination of the pump¿s interior components.Investigation did not duplicate the ¿no power¿ complaint and the pump was determined to be operating within the required specifications without malfunction.

• 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: 5517155
• MDR Text Key: 41030720
• Report Number: 2531779-2016-06370
• 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: 03/09/2016

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: 04/26/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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: 28 YR