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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 Bent (1059); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 11/16/2017
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Customer reported via phone call that her daughter received an insulin flow blocked alarm. The alarm occurred upon insertion of a new infusion set. Upon removal, customer noticed that the cannula was bent. Customer stated that her daughter's blood glucose level was high at the time of the incident, but she did not specify a blood glucose value. Customer declined troubleshooting for the high blood glucose value, the insulin flow blocked alarm, and the bent infusion set cannula. Blood glucose value is unknown. The infusion set is 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 Key7063699
MDR Text Key93583551
Report Number2032227-2017-68455
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 other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
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 Received11/20/2017
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

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