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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 Excess Flow or Over-Infusion (1311)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)
Event Date 03/17/2017
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

Customer reported via phone call that they experienced low blood glucose levels of 48 mg/dl. The customer did not mention any symptoms of their blood glucose levels. The customer did not mention any form of treatment for their blood glucose levels. The customer stated that their insulin pump went into suspend mode and they suffered high blood glucose levels prior. The customer was not connected to the insulin pump while priming the device. There was no indication that the insulin pump over delivered insulin. The customer did not troubleshoot and did not send the product back 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 Key6501703
MDR Text Key73249328
Report Number2032227-2017-19246
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 03/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2017
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
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 Received03/17/2017
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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