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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM POLYFIN FPA

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MEDTRONIC MINIMED PARADIGM POLYFIN FPA Back to Search Results
Model Number MMT-312S
Device Problems Air Leak (1008); Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 11/03/2013
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. Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014. Subsequently, medtronic diabetes conducted a one year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
 
Event Description
Customer reported via phone call that the insulin pump has been alarming no delivery and she had been experiencing high blood glucose. She mentioned she broke her neck and was in coma for 9 months. She has been going to the hospital but not due to high blood glucose. Her doctor has been changing her basal settings. She stated her blood glucose in the morning was 439 mg/dl and 101 mg/dl during the alarm. Customer was unable to run fixed prime as insulin pump kept alarming no delivery. She disconnected and reconnected the tubing and reservoir and there was resistance during manual prime. She tried again and was able to get insulin to exit. She mentioned the tubing had blood by the site. It was found the infusion sets were expired, the tubing had air bubbles and the time/date was incorrect. Blood glucose during air bubbles troubleshooting was 597 mg/dl. No insulin leaks found but insulin was not stored at room temperature. She was advised to discontinue the use of those infusion sets.
 
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Brand NamePARADIGM POLYFIN
Type of DeviceFPA
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5480326
MDR Text Key39675661
Report Number2032227-2016-04012
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K031917
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 11/03/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-312S
Device Catalogue NumberMMT-312S
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 Received11/03/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/04/2016 Patient Sequence Number: 1
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