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

Model Number MMT-551NAL

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

Patient Problems Death (1802); Depression (2361); Cognitive Changes (2551)

Event Date 07/04/2016

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 committed suicide.The caller stated that the customer had depression, was not taking care of himself and was using drugs.The caller stated that the customer was wearing the insulin pump at the time of death.The caller stated that the customer was using the sensors - off and on - however, the customer was not wearing a sensor at the time of death.The caller stated that the customer's insulin pump is in the coroner's possession, who is not releasing the device.

Manufacturer Narrative

Additional information has been received which was not included with the initial medwatch report.The additional information has been provided with this report.

Event Description

Information was received via email that the coroner has ruled out the insulin pump as a cause of death, and can now release the pump to be returned.The coroner has been calling the customer's family to get the pump returned.

Manufacturer Narrative

The insulin pump was returned with a (b)(4) alkaline battery.The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.The insulin pump was received with cracked reservoir tube lip, cracked battery tube threads and minor scratched lcd window.Data analysis: there is no data listed for the dated of (b)(6) 2016 due to the insulin pump was received depleted battery installed.

• 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: 5810588
• MDR Text Key: 50058712
• Report Number: 3004209178-2016-62066
• 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,Followup,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/30/2016; 09/21/2016
• 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 Outcome(s): Death
• Patient Age: 26 YR
• Patient Weight: 82