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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); Sticking (1597); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2017
Event Type  malfunction  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6). 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. 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 received a no delivery alarm. Customer reports that this occurred while attempting to administer a bolus. Customer's blood glucose at the time of the incident was 185 mg/dl. Customer is able to troubleshoot. Customer reports that after removing the infusion following the occlusion, they observed the infusion set cannula to be bent and angled to the side. Customer also reported experiencing problems with her serter becoming stuck. Customer was advised to replace her infusion set. The infusion set is 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 Key6988889
MDR Text Key91091045
Report Number2032227-2017-62853
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 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-397T
Device Catalogue NumberMMT-397T
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 Received09/25/2017
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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