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

Model Number MMT-7008A

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Hypoglycemia (1912)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Failure analysis inspected 1 opened/used sensor and performed continuity resistance test sensor passed per specification.Also performed bicarbonate buffer test.Sensor failed per specifications due to high readings.

Event Description

Customer called and reported that they received emergency medical assistance due to low blood glucose on september 29, 2017 with blood glucose of 34 mg/dl at the time of the incident.The customer was at 80 mg/dl at the time of the call.The customer used candy to treat.The customer was wearing the insulin pump during the incident.The customer was the driver during a car accident while wearing the pump.Troubleshooting was not completed as the customer declined.The customer also reported sensor glucose versus blood glucose differences.The insulin pump will not be returned for analysis.Sensor failed per specifications due to high readings.

• 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: 7594476
• MDR Text Key: 110849558
• Report Number: 2032227-2018-05312
• 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
• Report Date: 06/12/2018

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-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 06/12/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 90