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)

Event Date 12/18/2014

Event Type  Death  

Event Description

It was reported that the customer passed away at home, in her sleep.At this time the cause of death is unknown.The caller stated that an autopsy is being performed and it will be a while before he finds out the official cause of death and receives the death certificate.The caller stated that the customer had multiple surgeries because of a staph infection in her foot.The issue began in (b)(6) 2014.The customer's blood glucose at the time of death was unknown.The customer was wearing the insulin pump at the time of death.She was not using sensors and was not wearing one at the time of death.The caller stated that insulin pump was still at the funeral home.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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

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.

Manufacturer Narrative

The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.The device had a cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked lcd window and cracked belt clip slot.Data analysis customer daily insulin total average from 61.2 to 108.95u, total basal insulin from 36.75 to 61.2 and total bolus insulin 0 to 67.0u.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 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: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4410701
• MDR Text Key: 5280087
• Report Number: 3004209178-2015-82915
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Date Manufacturer Received: 05/06/2015
• 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 Age: 41 YR
• Patient Weight: 122