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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-318
Device Problems Fluid Leak (1250); Sticking (1597)
Patient Problem Hyperglycemia (1905)
Event Date 11/15/2013
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. See manufacturer report number 2032227-2013-05920. 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 initially called for assistance with priming. The customer stated she changed the infusion set but was stuck in the fill tubing step. During the call, she reported that she was admitted into the hospital on (b)(6) 2013 due to high blood glucose and was still in the hospital. Customer's blood glucose value was over 500 mg/dl. The customer reverted to manual injections. She was about to be discharged and was trying to reconnect the insulin pump to make sure it was functioning. Blood glucose value was 225 mg/dl. Customer stated that insulin was squirting out of the tubing during manual prime but no gap seen the piston and reservoir stopper. The customer was unsure if the drive support cap was protruded or loose. The insulin pump was replaced and returned for analysis.
 
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Brand NameSOF SET ULTIMATE
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 Key5480329
MDR Text Key39673286
Report Number2032227-2016-04014
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 11/17/2013
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-318
Device Catalogue NumberMMT-318
Device Lot NumberUNK318
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 Received11/17/2013
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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