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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 Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 10/05/2017
Event Type  Injury  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 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. 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 reports that they have been having high blood glucose levels between 350 mg/dl and 400 mg/dl for the past week. Customer reports that they went to the doctor after the first high blood glucose incident. Customer reports that she ate late at night which may have contributed to the elevated blood glucose. Customer reports that she typically eats smaller amounts of food during the day and consumes more food later at night. Customer reports that her current blood glucose is 342 mg/dl. Customer reports that while changing her infusion set, she observed the infusion set cannula to be bent. Customer reports difficulty with having her serter release properly. 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 Key6987538
MDR Text Key90567272
Report Number2032227-2017-62713
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
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397T
Device Catalogue NumberMMT-397T
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 Received10/15/2017
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: 10/30/2017 Patient Sequence Number: 1
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