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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE OZO

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MEDTRONIC MINIMED SENSOR ENLITE OZO Back to Search Results
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.

 
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Brand NameSENSOR ENLITE
Type of DeviceOZO
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 Key5658258
MDR Text Key45428361
Report Number2032227-2016-10880
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
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 Received05/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device LOT NumberHG0NVKU
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 Received04/26/2016
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

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