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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 01/25/2016
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 reported via phone call that they experienced a high blood glucose level of over 600 mg/dl. Customer treated the elevated blood glucose with manual injections of insulin. Customer reported removing their infusion set and finding that the infusion set cannula was bent. Customer believes that the high blood glucose level was due to the bent infusion set cannula. Customer was able to troubleshoot during the call. 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 Key7225285
MDR Text Key98463194
Report Number2032227-2018-01049
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 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
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 Number5122025
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 Received01/25/2016
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: 01/29/2018 Patient Sequence Number: 1
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