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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-UNK
Device Problems Air Leak (1008); Bent (1059)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Swelling (2091); Blurred Vision (2137); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 08/21/2013
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.
 
Event Description
Customer reported via phone call high blood glucose, bent cannula and hospitalization. Customer's blood glucose level was 453 mg/dl. Troubleshooting for high blood glucose was performed. Customer treated their high blood glucose via manual injection. Customer advised insulin did not exit out of the infusion set when tested at the hospital. Customer experienced swelling in the mouth, lost equilibrium, vision loss, vomiting and extreme dehydration. Customer believed they experienced diabetic ketoacidosis, were hospitalized and placed in the intensive care unit. Customer was wearing the insulin pump while admitted at the hospital, was then placed on insulin drip, fluids and antibiotics. Customer advised the insulin pump had air bubbles inside of the tubing while attempting to prime. Customer performed the high pressure test and passed. Customer advised the bent cannula left a v shaped mark on their skin.
 
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Brand NameINFUSION SET
Type of DeviceFPA
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 Key5581633
MDR Text Key42811743
Report Number2032227-2016-09180
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 consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 08/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-UNK
Device Catalogue NumberMMT-UNK
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 Received08/23/2013
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: 04/15/2016 Patient Sequence Number: 1
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