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

Model Number MMT-751NAL

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

Patient Problems Bacterial Infection (1735); Death (1802); Hyperglycemia (1905); Renal Failure (2041)

Event Date 12/17/2015

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.

Event Description

It was reported that the customer passed away in a hospital. The customer was hospitalized on (b)(6) 2015. The cause of death was (b)(6). The customer had kidney failure; stage 3 or 4 renal disease. The customer's blood glucose at the time of death was 250 mg/dl. The customer was not wearing the insulin pump at the time of death. It was disconnected on (b)(6) 2015 by the instructions of the hospital. They stated that the hospital staff would treat the customer's blood glucose. The customer was not using sensors. The caller stated that they do not know where the insulin pump is and declined returning it for analysis.

• 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: 5369038
• MDR Text Key: 36022703
• Report Number: 3004209178-2016-81373
• 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: 01/13/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/14/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2016
• 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: Unkown

Patient TREATMENT DATA

Date Received: 01/14/2016 Patient Sequence Number: 1