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

Model Number MMT-551NAH

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

Patient Problems Death (1802); Hyperglycemia (1905); Hypoxia (1918); Brain Injury (2219); Diabetic Ketoacidosis (2364)

Event Date 05/17/2016

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 passed away at home.The cause of death was ketoacidosis, possible stroke, oxygen deprivation to brain damage.The caller stated that on (b)(6) 2016 the customer was hospitalized due to high blood glucose and ketoacidosis.The caller stated that the customer was a brittle diabetic.At the time of death, the customer's blood glucose was over 600 mg/dl.This was the last recorded blood glucose value on (b)(6) 2016 at 5:56pm.The customer was not wearing the insulin pump at the time of death; it had been disconnected one week prior to passing.The insulin pump was disconnected by the caller so that the hospital could control the customer's blood glucose.The customer was using sensors, however, the caller did not know whether a sensor was worn at the time of death or not.The caller declined returning the insulin pump at this time.However, a successful carelink upload was completed.

Manufacturer Narrative

This correction report is being submitted because the initial medwatch report was incorrectly marked as serious injury.The correction has been made in this report, and is now correctly marked as death.

• 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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5674220
• MDR Text Key: 45750592
• Report Number: 3004209178-2016-50123
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• 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: 52 YR
• Patient Weight: 66