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

Model Number MMT-751NAS

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Date 03/18/2016

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.His body was found on a hiking trail.The caller stated that at this time, the cause of death is unknown.The caller stated that there were circumstances surrounding the customer's death, therefore, it is under investigation.The caller stated that it takes approximately three months to get a death certificate from the coroner's office.The caller stated that they do not have the customer's insulin pump; it is being kept by the coroner's office for evidence.The police informed the caller that when the customer's body was found, he was wearing the insulin pump.Since the caller did not have the insulin pump at the time of the phone call, the device information could not be verified.The insulin pump information used on this medwatch report is the last known insulin pump to have been issued to the customer.

• 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: 5543243
• MDR Text Key: 41715562
• Report Number: 3004209178-2016-97128
• 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
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2016
• 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: 03/31/2016
• 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: 56 YR
• Patient Weight: 86