MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 11/03/2021

Event Type  Injury  

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

Information received by medtronic indicated an inaccurate sensor reading that triggered a suspend.On november 16, 2021, it was reported that the blood glucose was 251 mg/dl and the sensor glucose was 62 mg/dl, which is outside of the acceptable range.The customer was previously hospitalized for 8 days starting on (b)(6) 2021 with a high bg of 400 mg/dl and symptoms including nausea, vomiting, and abdominal pain.The customer declined troubleshooting.No further patient complications were reported.After hospitalization, the customer changed their pump settings with the assistance of their hcp and continued to use the device.The device is not expected to return to medtronic.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13948851
• MDR Text Key: 288182700
• Report Number: 2032227-2022-173900
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000020763000421292
• UDI-Public: (01)000020763000421292(17)211130(10)F0321P
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: F0321P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2021
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1