MAUDE Adverse Event Report: MEDTRONIC MINIMED INFUSION SET; FPA

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.

• Brand Name: INFUSION SET
• Type of Device: FPA
• 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 Key: 5581633
• MDR Text Key: 42811743
• Report Number: 2032227-2016-09180
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-UNK
• Device Catalogue Number: MMT-UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 68