MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; OZO

Model Number MMT-751NAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 01/05/2015

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.(b)(4).

Event Description

It was reported by the legal representative of the decedent's family that on (b)(6) 2014 the customer was found at home, unresponsive.The paramedics were unable to obtain a blood glucose reading and the customer was admitted to the intensive care unit with severe hypoglycemia and seizures; this resulted in altered mental status.The customer died of complications on (b)(6) 2015.

Manufacturer Narrative

Medtronic legal received information regarding the customer's passing from the attorney of the family.The information received on 08/01/2016 stated the following- reporter alleges: "on or about (b)(6) 2014, the customer was shipped an insulin pump which did not have all of the features and functionality anticipated by the customer's physician.The insulin pump provided to the customer did not have the ability to automatically shut off when low blood glucose levels were detected.On or about (b)(6) 2014 while using this insulin pump and related equipment, the customer was found unconscious in his home.The customer received emergency health care, and was diagnosed as suffering from low blood glucose, caused by the over delivery of insulin.The insulin pump failed to warn him when his blood sugar was dropping to low levels, and did not shut off when the blood sugars were dangerously low.As a result of these defects, the customer experienced hypoglycemia, diabetic coma, and acute encephalopathy.As a result of these injuries, the customer required extensive medical treatment and monitoring, up until his death on (b)(6) 2015.The customer died as a result of the injuries he suffered, which were caused by the defects in the insulin pump and related equipment.".

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• 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: 5205969
• MDR Text Key: 30568186
• Report Number: 2032227-2015-64032
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2016
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 95