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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Dizziness (2194)
Event Date 04/16/2020
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 reported via phone call that they were experiencing high blood glucose level. Blood glucose level at the time of the incident was 475 mg/dl, 550 m g/dl, 560 mg/dl, below 400 mg/dl. Customer experienced symptoms such as dizziness. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer did not allege insulin pump was under delivering. Customer was not using auto mode. Troubleshooting was performed. The insulin pump will not be returned for analysis.
 
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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
8185464805
MDR Report Key9979373
MDR Text Key188981443
Report Number2032227-2020-106548
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
Reporter Occupation
Type of Report Initial
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399T
Device Catalogue NumberMMT-399T
Device Lot Number5284942
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2019
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: 04/20/2020 Patient Sequence Number: 1
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