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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 Insufficient Information (3190)
Patient Problems Syncope (1610); Hyperglycemia (1905)
Event Date 04/02/2017
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
The customer reported via phone call that they were hospitalized on (b)(6) 2017 with a blood glucose level of 281 mg/dl.The customer was found passed out but they stated that they were not hospitalized for diabetes related issues or any issues with the insulin pump.The customer experienced no symptoms.The customer was wearing the insulin pump during the hospitalization.The customer did not troubleshoot and did not send the product back for analysis.
 
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Brand Name
SENSOR ENLITE
Type of Device
OZO
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 Key6537400
MDR Text Key74406828
Report Number2032227-2017-19330
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 04/02/2017
Initial Date FDA Received05/02/2017
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 Unknown
Patient Sequence Number1
Patient Age55 YR
Patient Weight69
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