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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-396T
Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2016
Event Type  malfunction  
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 that they received a no delivery alarm. Customer's blood glucose level at the time of the incident was 152 mg/dl. Customer was able to troubleshoot. Customer disconnected at the quick release and attempted to perform a fixed prime. Customer reported that insulin did not exit the infusion set tubing and the pump continued to alarm no delivery. Customer reported that insulin also did not exit when attempting to push it through with a plunger. The product is expected to be returned.
 
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Brand NamePARADIGM QUICK SET MMT-396T
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 Key7238603
MDR Text Key99101367
Report Number2032227-2018-01225
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 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberMMT-396T
Device Catalogue NumberMMT-396T
Device Lot Number5138199
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 Received12/04/2016
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

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