MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

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

Patient Problems Death (1802); Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Coma (2417)

Event Date 03/18/2018

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) 2017.The cause of death was a seizure attack and a diabetic coma.The caller stated that they did not know if the customer had any other illnesses that may have led to the customer's passing.The customer¿s blood glucose was 26 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 more than 48 hours prior to passing, at the time of admission.The caller stated the customer was taken off the pump and put on intravenous insulin.The customer was not using sensors.The customer went to sleep on (b)(6) 2017 and never woke up again.The caller declined to return the insulin pump for analysis.

Manufacturer Narrative

The information related to date of hospitalization and date of passing provided with initial report was incorrect.(b)(4).

Event Description

The correct date of hospitalization is (b)(6) 2018 and customer passing was on (b)(6) 2018.The customer went to sleep on march 17, 2018 and never woke up again.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 10776013
• MDR Text Key: 214286838
• Report Number: 2032227-2020-200047
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169656840
• UDI-Public: (01)000000643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1E58P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• 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; Hospitalization
• Patient Age: 29 YR