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

Model Number MMT-7008A

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 02/25/2018

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 reported via phone call that the customer¿s blood glucose was low and the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 143 mg/dl and the sensor glucose was 55mg/dl at the time of the incident. The customer reported that sensor glucose and blood glucose difference is not within acceptable range. Insulin delivery was suspended due to sensor glucose value of 52mg/dl. Low suspend limit in sensor settings was 70. Customers current blood glucose was 200mg/dl. Customer states the drive support cap appears normal. Based on customer report proceeding in troubleshooting the customer was alleging possible pump over delivery. The customer¿s blood glucose was 93mg/dl. Also sensor glucose was 135mg/dl when blood glucose 97mg/dl. The customer also reported sensor glucose value of 71mg/dl and then blood glucose 128mg/dl. Also blood glucose was 170mg/dl. The sensor will be returned for analysis. The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information provided in concomitant reporting section with the initial report was incorrect. The correct information has been included with this report.

• 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: 7636861
• MDR Text Key: 112275183
• Report Number: 2032227-2018-07334
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 06/26/2018 Patient Sequence Number: 1

Treatment

MMT-551NAS