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

Model Number MMT-751LNAS

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

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 12/15/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).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 via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2020.The cause of death was diabetic ketoacidosis.The caller stated that the customer had no other illnesses that may have led to the customer's passing.The customer¿s blood glucose was over 1000 mg/dl at the time of admission.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.The caller stated the customer may have taken off the pump to shower, but was not sure.The caller was unsure if the customer was using sensors.The caller stated that the customer's blood glucose was low at 5 am on the morning of (b)(6) 2020.The caller stated the customer was given a soda to treat, and when the caller returned home after going to work, they found the customer unconscious and the soda was empty.The customer did not have the pump on her at that point.The caller agreed to return the insulin pump for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 11107363
• MDR Text Key: 224737172
• Report Number: 2032227-2021-100269
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000161170
• UDI-Public: (01)000000763000161170
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A6751LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Date Device Manufactured: 05/22/2020
• 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-MMT-326-RSVR, UNOMED SET.
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 61