MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE OZO

Model Number MMT-7008A

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 02/11/2015

Event Type  Injury  

Event Description

It was reported that the customer's sensor site got infected. The infection occurred on the second week of having the insulin pump. The sensor site had staphylococcus. Her blood glucose level was not reported. The product was not returned. Nothing further to report.

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

• Brand Name: SENSOR ENLITE
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4528546
• MDR Text Key: 16862597
• Report Number: 2032227-2015-07224
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/19/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown