MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/01/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Medtronic legal received information regarding the customer¿s passing from the attorney of the family.The information received on (b)(6) 2020 stated that the customer had passed away possibly due to hyperglycemia and hypoglycemia, and their next of kin had filed a lawsuit against medtronic.The reporting party declined to provide further information.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 10912760
• MDR Text Key: 218483976
• Report Number: 2032227-2020-210792
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169873834
• UDI-Public: (01)000000643169873834
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/26/2020

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-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG25793
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/26/2020
• Date Device Manufactured: 11/18/2017
• 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: 67 YR
• Patient Weight: 123