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

Model Number MMT-751NAH

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Hyperglycemia (1905); Unspecified Infection (1930); Renal Failure (2041); Injury (2348); Respiratory Failure (2484)

Event Date 02/06/2015

Event Type  Death  

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.However, the insulin pump had a cracked reservoir tube lip.No data was available because the insulin pump was received without a battery installed.

Event Description

It was reported that the customer passed away in hospice.The caller stated that the cause of death was respiratory failure/diabetes related.The customer was hospitalized in (b)(6) 2014 and had numerous hospitalizations before christmas.The customer was sent to rehabilitation, and then she was released to manage her blood glucose on her own, which, she was unable to do, and lead to the hospitalizations and the hospice care.The customer was on dialysis, had a major stomach infection and had bad sore on her back.Dialysis and all life support were stopped, and the customer was moved to hospice.The customer had high blood glucose, renal failure, frontal lobe stroke, and a stomach infection.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 and had been disconnected since (b)(6) 2014 due to the nurses' request.The customer was not using sensors.The insulin pump will not be returned.

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.

Manufacturer Narrative

Information has been updated which was not included with initial.The information has been provided with this report.The insulin pump passed the delivery volume accuracy test.

• 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: 4783357
• MDR Text Key: 13303845
• Report Number: 3004209178-2015-53587
• 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,Followup,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/25/2015
• Date Manufacturer Received: 05/18/2015
• 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 Outcome(s): Death
• Patient Age: 51 YR