MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE OZO

Model Number MMT-7008A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hyperglycemia (1905)

Event Date 03/13/2016

Event Type  Malfunction  

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.

Event Description

It was reported via phone call that customer had staph infection due to sensor. Customer visited healthcare professional and was put on antibiotics. Customer's blood glucose was between 400 mg/dl and 500 mg/dl, which was treated with manual injections.

• 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 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5658258
• MDR Text Key: 45428361
• Report Number: 2032227-2016-10880
• 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: 04/26/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/16/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device LOT Number: HG0NVKU
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/26/2016
• 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