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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-397T
Device Problems Bent (1059); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 10/28/2017
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. 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 they experienced a high blood glucose level. Customer's blood glucose was 350 mg/dl at 11:30 am. One hour later, at 12:30 pm on the same day, the customer's blood glucose level was 359 mg/dl. Customer declined troubleshooting for the elevated blood glucose. Customer was able to troubleshoot their products. Customer feels that their quick serter is malfunctioning. During troubleshooting, customer reports that their serter is not releasing the infusion set when serter is loaded and buttons are pressed. Upon removal of current infusion set, customer observed that the infusion set cannula was bent. Bent infusion set cannula occurred during the customer's first day of using the infusion set. Customer was advised to replace the return the infusion set with the bent cannula and the quick serter that would not release. The products are expected to be returned.
 
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Brand NamePARADIGM QUICK SET MMT-397T
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 Key6993439
MDR Text Key90779009
Report Number2032227-2017-63221
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
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397T
Device Catalogue NumberMMT-397T
Device Lot Number5189430
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 Received10/28/2017
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

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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