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

Model Number MMT-751NAP

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Death (1802); Renal Failure (2041)

Event Date 12/26/2014

Event Type  Death  

Event Description

It was reported that the customer passed away at home, in hospice care. The cause of death was complications from c. Diff (clostridium difficile). The customer was hospitalized on (b)(6) 2014 for a minor foot surgery. The customer went to rehabilitation and acquired c. Diff. The customer's kidneys stopped functioning. He had a heart attack in 2009. The customer's blood glucose at the time of death was unknown. The customer was not wearing the insulin pump at the time of death; it was removed at the hospital when he was hospitalized for surgery on (b)(6) 2014. It caller did not know if the customer used sensors. The caller stated that she does not have the insulin pump and cannot send it for analysis because the device was taken from the customer at the hospital; she was told that c. Diff stays attached to the device for two years. The caller did not have the device at the time call so the serial number could not be verified. No further information is available at this time.

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.

• 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 386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 386
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4410686
• MDR Text Key: 5279523
• Report Number: 3004209178-2015-82913
• 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: 01/09/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/12/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available For Evaluation?: No
• Date Manufacturer Received: 01/09/2015
• 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: Unkown

Patient TREATMENT DATA

Date Received: 01/12/2015 Patient Sequence Number: 1