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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 Problem Air Leak (1008)
Patient Problem Hyperglycemia (1905)
Event Date 01/13/2014
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 mdr number 2032227-2016-04017.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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 she had been experiencing high blood glucose all day.Customer's blood glucose at the time of the call was 500 mg/dl, which she treated with the insulin pump.The insulin pump's troubleshooting was done but the customer was unable to perform the high pressure test as she didn't have a tubing clamp and was advised to call back to complete troubleshooting.The customer called back later to report she changed the infusion set and reservoir but had air bubbles in the tubing.Customer stated the insulin pump was not rewound with a reservoir in place but insulin was not stored at room temperature.Customer was assisted with purging the air bubbles out.The customer was advised to change the infusion.It was found that the customer was using expired infusion sets.Product was not replaced or 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 Key5483635
MDR Text Key39783150
Report Number2032227-2016-04016
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 01/13/2014
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 Number640229
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/13/2014
Initial Date FDA Received03/07/2016
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight67
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