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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 Problems Excess Flow or Over-Infusion (1311); Device Remains Activated (1525)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 08/07/2015
Event Type  Injury  
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

Customer reported via phone call, on (b)(6) 2015 the insulin pump didn't may any noise or signal that her blood glucose was lowering. Customer stated her blood glucose was 28 mg/dl and the sensor didn't trigger the threshold suspend feature on the device. Current blood glucose was 400 mg/dl. Troubleshooting for low blood glucose was performed. Customer stated she was admitted for medical treatment due to the low. She was also in a vehicular accident where she was the driver. Customer stated prior the issue customer was active all day, had supper, and she was at baseball game. She had the accident on her way home from the game. Customer was unsure what the cause of the low might have been. No troubleshooting was performed on the sensor. The sensor is not returning for analysis.

 
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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 Key5041065
MDR Text Key24520971
Report Number2032227-2015-38005
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 08/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-7008A
Device Catalogue NumberMMT-7008A
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 Received08/10/2015
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

Patient TREATMENT DATA
Date Received: 08/29/2015 Patient Sequence Number: 1
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