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

Model Number MMT-7008A

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364)

Event Date 11/23/2017

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer's mother reported via phone call that they were hospitalized due to diabetic ketoacidosis on (b)(6) 2017 at 11:00 pm with blood glucose of 600 mg/dl.Patient's current blood glucose was 173 mg/dl.Customer reported that before hospitalization on same day patient¿s blood glucose was in 200¿s mg/dl and treated it with manual injection.Customer reports they feel okay to troubleshoot.The customer experienced symptoms such as trace ketones, didn¿t feel well, nausea and fatigue.Customer reports they have contacted their healthcare provider regarding the high blood glucose.Customer was in emergency room as a result of high blood glucose.The customer was wearing the insulin pump during the hospitalization.The sensor will be returned for analysis.

• 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 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7497296
• MDR Text Key: 107686267
• Report Number: 2032227-2018-02995
• Device Sequence Number: 1
• Product Code: OZO
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 112