MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAP

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

Patient Problems Death (1802); Shock, Insulin (2264)

Event Date 03/31/2019

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 at home.The cause of death was undetermined but the caller believes the customer went into diabetic shock, fell into a tub, and drowned.The caller stated that the customer had no other illnesses that may have led to the customer's passing.The customers blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected within 24 hours prior to passing, so the customer could take a bath.The customer was not using sensors.The caller declined to return the insulin pump for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 8526574
• MDR Text Key: 142322629
• Report Number: 3004209178-2019-83991
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507777
• UDI-Public: (01)00643169507777
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Device Lot Number: A4751LNAPJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2016
• 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
• Treatment: FRN-UNK-RSVR , UNOMED SET
• Patient Outcome(s): Death
• Patient Age: 39 YR