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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 Problem Obstruction of Flow (2423)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Blood Loss (2597)
Event Date 02/29/2020
Event Type  Injury  
Manufacturer Narrative
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. (b)(4).
 
Event Description
Customer reported via phone call that they experienced high blood glucose and they allege insulin pump was under delivering. The customer blood glucose level was 479 mg/dl at the time of incident. Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer reported that they received insulin flow blocked alarm. Customer stated the insulin was exited. Customer stated the cannula was not bent. Customer had a high blood glucose because of the blood and bruise on site. Customer treated with shot. The customer was assisted with troubleshooting and declined for high blood glucose. The insulin pump and reservoir will not be returned for analysis.
 
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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
8185464805
MDR Report Key9791594
MDR Text Key182126551
Report Number2032227-2020-101611
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
Type of Report Initial
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-396T
Device Catalogue NumberMMT-396T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2020
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: 03/05/2020 Patient Sequence Number: 1
Treatment
UNOMED SET
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