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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 Bent (1059); Use of Device Problem (1670); Material Protrusion/Extrusion (2979)
Patient Problems Overdose (1988); Loss of consciousness (2418); Sweating (2444)
Event Date 03/25/2015
Event Type  Malfunction  
Manufacturer Narrative

Reliability analysis: inspected (b)(4) opened/used sensors and performed a visual inspection and found (b)(4) sensors with the cannula retracted inside of the sensor base. They also found the cannula to be damaged (broken) and the broken part was missing. Among the (b)(4) remaining sensors, they found the needle hubs were separated from the sensor base. They were unable to confirm that the customer received the sensors in said condition due to the customer having returned opened/used sensors. Customer also had a complaint against the sen serter.

 
Event Description

The customer reported via phone call that she is on her third sensor and she cannot get the sensor on. Customer stated that the needle was bent. Customer's blood glucose was 123 mg/dl. Customer had the wrong serter and will be sent an enlite serter. Customer was advised that the sensors will be replaced. Customer stated that the paramedics had to be called because her father's the pump gave him over 150 units. Customer stated that her mother called 911 and her dad was on chemotherapy. Customer stated that her dad's pump was not indented but it was sticking out. Customer's mother woke up to find him unconscious and soaked. Customer's brother also had a drive support cap that was sticking out and his insulin pump was replaced.

 
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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 Key5077859
MDR Text Key26204780
Report Number2032227-2015-42768
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
Type of Report Initial
Report Date 03/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2015
Was Device Evaluated By Manufacturer? Yes
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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