MAUDE Adverse Event Report: MEDTRONIC MINIMED INFUSION SET; FPA

Model Number MMT-UNK

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 04/07/2016

Event Type  Death  

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 that the customer's blood glucose was above 25 mmol/l after he passed away.It was also noted that prior to passing the customer gave a bolus, was nauseous, was vomiting, but did not contact the health care professional.The day before the bolus the customer changed the infusion set and the reservoir; possible cannula break.The caller stated that since the customer passed away at home, it is unknown whether they were wearing the insulin pump at the time of death or not.The caller stated that since the customer did not contact the health care profession not much information is available.

• Brand Name: INFUSION SET
• 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 Key: 5685943
• MDR Text Key: 46127641
• Report Number: 2032227-2016-12074
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• 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: 05/20/2016
• 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 Number: 1
• Patient Outcome(s): Death