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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFUSION SET FPA

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MEDTRONIC MINIMED INFUSION SET FPA Back to Search Results
Model Number MMT-XXX
Device Problem Bent (1059)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 02/12/2017
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.
 
Event Description
It was reported via phone call that customer was hospitalized on (b)(6) 2017 with blood glucose of 600 mg/dl. Customer was hospitalized due to diabetic ketoacidosis and was in a coma in the intensive care unit. Customer was still hospitalized in coma at the time of call. Caller was not sure if customer was wearing insulin pump at the time of hospitalization. Troubleshooting was performed for high blood glucose and it was found that cannula was bent. It was also found that time was 6 minutes off. Caller was not able to troubleshoot for bent cannula. Caller was advised to have customer or family call.
 
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Brand NameINFUSION SET
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 Key6412029
MDR Text Key70172391
Report Number2032227-2017-12745
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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