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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 Air Leak (1008)
Patient Problem Hyperglycemia (1905)
Event Date 09/04/2016
Event Type  Injury  
Manufacturer Narrative
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.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 they experienced a blood glucose level.Customer's blood glucose at the time of the incident was 499 mg/dl.Customer was able to troubleshoot during the call.Customer reported finding air bubbles in the reservoir during troubleshooting.Customer reported finding two air bubbles.Customer reported that the first air bubble was approximately 2 centimeters wide, while the second air bubble was 4 centimeters wide.Customer reported that the air bubbles did not persist after changing her infusion set.No product is expected to be returned.
 
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Brand Name
PARADIGM QUICK SET MMT-397T
Type of Device
SET, 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 Key7148976
MDR Text Key95858807
Report Number2032227-2017-77450
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 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-397T
Device Catalogue NumberMMT-397T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight113
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