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

Device Problem 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.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.(b)(6).

Event Description

On (b)(6) 2016 the reporter contacted animas alleging that on (b)(6) 2016 the battery became very warm so that the patient could not hold the pump.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the issue remained unresolved.

Manufacturer Narrative

Follow-up #1: date of submission 04/26/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: a review of the black box indicated a drastic voltage drop that led to the pump getting warm on (b)(6) 2016.No activity outside normal use was found in the pump histories for (b)(6) 2016.Visual inspection did not find any damage to the battery compartment or cap.The pump powered on normally and successfully completed rewind, load, and prime steps.All current draws were within specifications during investigation; no overheating occurred.The pump cover was removed and no internal defects were found.The complaint could not be duplicated on investigation.Unrelated to the complaint, investigation revealed that the display was dim and discolored.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: 5543687
• MDR Text Key: 41958039
• Report Number: 2531779-2016-07055
• 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: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• 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: 04/04/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 45 MO
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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