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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-399T
Device Problems Partial Blockage (1065); High Test Results (2457); Device Displays Incorrect Message (2591)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 04/12/2018
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's mother reported via phone call that her son was hospitalized due to experiencing an episode of diabetic ketoacidosis. Customer's blood glucose level at the time of hospitalization due was 600 mg/dl. Customer's mother reported that her son was treated with a manual drip of insulin. Customer's current blood glucose level is 200 mg/dl. Customer's mother also reported a past event of receiving an insulin flow blocked alarm that was resolved by a complete infusion set change including the reservoir and the infusion set. The infusion set is not expected to be returned.
 
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Brand NamePARADIGM QUICK SET MMT-399T
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7440566
MDR Text Key105837353
Report Number2032227-2018-02620
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399T
Device Catalogue NumberMMT-399T
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 Received04/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/18/2018 Patient Sequence Number: 1
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