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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED SOF SET MIRCO; FPA Back to Search Results
Model Number MMT-325
Device Problems Air Leak (1008); Bent (1059); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Vomiting (2144)
Event Date 01/25/2014
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.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 she has been experiencing high blood glucose for 4 days.Blood glucose value was 494 mg/dl.She experienced vomiting and dry mouth.She had treated with manual injections.During troubleshooting; the customer found a small and a larger air bubble in the infusion set's tubing and small bubbles in the reservoir.No insulin leaks noted.She removed the infusion set and found blood in the cannula and it was bent.The insulin pump was not rewound with a reservoir in place and insulin was not stored at room temperature but it was left out for 30 min to bring to room temperature.The insulin pump passed the high pressure test.She was advised to change the entire set, reservoir and insulin.When the customer primed the new tubing, insulin started squirting out.No compromised force sensor alarms were found in the alarm history or other issues with the insulin pump were noted.The customer changed the infusion set and reservoir and was able to prime.
 
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Brand Name
SOF SET MIRCO
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 Key5483639
MDR Text Key39782260
Report Number2032227-2016-04018
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K001827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 01/27/2014
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-325
Device Catalogue NumberMMT-325
Device Lot Number50721558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/27/2014
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 Age73 YR
Patient Weight61
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