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

Model Number MMT-751NAH

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Fever (1858); Hyperglycemia (1905); Renal Failure (2041); Complaint, Ill-Defined (2331)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with alkaline battery installed.The insulin pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test and excessive no delivery test.The device had intermittent button response due to flattened dome switches at the esc, act, up arrow and down arrow buttons; there was no crease.The keypad connector on the lcd board was locked.The insulin pump had minor scratched display window, scratched reservoir tube window and a small crack on the reservoir tube lip.Data analysis: the download history file lists data from 10/26/16 to 11/07/16.There was no data listed for july 2016.(b)(4).

Event Description

It was reported that the customer passed away in a hospital.The customer was hospitalized on (b)(6) 2016.The cause of death was congestive heart failure.The caller stated that the customer had heart murmur and had been treated for atrial fibrillation.The caller stated that the customer became ill one week prior to passing.Also, the caller stated that the customer's pancreas was not functional, the customer had kidney failure and was constantly monitored, and, when preparing for a valve replacement, the customer had developed fever which could not be brought down.The customer was not wearing the insulin pump at the time of death; it had been disconnected fourteen days prior to passing.The caller did not know the customer's blood glucose at the time of death; however, the last recorded value was 132 mg/dl on (b)(6) 2016.The customer was using sensors, but was not wearing one at the time of death.The caller agreed returning the insulin pump.

• 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: 6107739
• MDR Text Key: 60550287
• Report Number: 2032227-2016-36379
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: P120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 68 YR
• Patient Weight: 104