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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SOF SET ULTIMATE; FPA

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MEDTRONIC MINIMED SOF SET ULTIMATE; FPA Back to Search Results
Model Number MMT-317
Device Problems Air Leak (1008); Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 10/28/2013
Event Type  Injury  
Manufacturer Narrative
One opened/used infusion set was inspected and manual prime test was performed using a new lab reservoir along with an insulin pump.The infusion set failed per specifications due to being occluded at the tubing quick release connection septum side.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
The customer reported via phone call that the insulin pump alarmed no delivery.The customer had changed the infusion set three times but the alarm was recurring and her blood glucose was high at 548 mg/dl.Customer confirmed that the reservoir was not empty and the tubing did not have air.The customer disconnected and was able to perform fixed prime.She was advised there may be a site related issue.The customer removed the infusion set and stated the cannula was not bent.The infusion set was replaced and returned for analysis.
 
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Brand Name
SOF SET ULTIMATE
Type of Device
FPA
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 Key5480324
MDR Text Key39673495
Report Number2032227-2016-04010
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K001832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 10/28/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-317
Device Catalogue NumberMMT-317
Device Lot Number50669667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/28/2013
Initial Date FDA Received03/04/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
Patient Weight97
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