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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535); Calibration Problem (2890)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)
Event Date 08/30/2015
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

The customer reported via phone call that his sensor glucose was 51 mg/dl but his blood glucose was 450 mg/dl. The patient treated his high with an insulin pump bolus. The customer also mentioned that the difference in readings has caused him to overtreat for his blood glucose and experience hypoglycemic events as well. Troubleshooting was initiated for the disparity between the sensor glucose and blood glucose readings. The customer was assisted with properly calibrating the sensor and general sensor use. No products were returned and a replacement sensor was shipped to the customer.

 
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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 Key5088940
MDR Text Key26227818
Report Number2032227-2015-46399
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2015
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 Received08/30/2015
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: 09/18/2015 Patient Sequence Number: 1
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