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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-398T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-398T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-398T
Device Problems Air Leak (1008); Insufficient Flow or Under Infusion (2182)
Patient Problem Hyperglycemia (1905)
Event Date 12/24/2017
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. 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 had high blood glucose value. Customer¿s blood glucose value at time of incident was 347 mg/dl and current blood glucose value was 75 mg/dl. Customer treated it manually. Customer alleged the insulin pump of under delivery. Customer also mentioned about leak in the reservoir past first o-ring and air bubbles measuring 5 inches in length in the infusion set tubing. Customer also reported observing a bent infusion set cannula. The infusion set will be returned for analysis.
 
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Brand NamePARADIGM QUICK SET MMT-398T
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 Key7210898
MDR Text Key97995868
Report Number2032227-2018-00895
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 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-398T
Device Catalogue NumberMMT-398T
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 Received12/27/2017
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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