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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-396T
Device Problems Kinked (1339); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 11/01/2015
Event Type  malfunction  
Manufacturer Narrative
This is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2017. Subsequently, medtronic diabetes conducted a two year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria. 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 he had four infusion set that had kinks in them and would not deliver insulin. Customer reported that pump alarmed no delivery. Customer's blood glucose level rose to the 300s during the incident. Customer's elevated blood glucose did not cause a serious injury or result in hospitalization or a visit to the er. No product is expected to be returned.
 
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Brand NamePARADIGM QUICK SET MMT-396T
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 Key7195150
MDR Text Key97668767
Report Number2032227-2018-00674
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 01/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-396T
Device Catalogue NumberMMT-396T
Device Lot Number5105632
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 Received12/01/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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